PHARMASEAL EYE PREP TRAY— 510(k) K850119

Name: FDA 510(k) clearance K850119
Creator: U.S. Food and Drug Administration
Published: 1985-05-09

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K850119 for PHARMASEAL EYE PREP TRAY, Substantially Equivalent on 1985-05-09. Applicant: American Pharmaseal Div. Ahsc. Device class: 1.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-01-14
Decision date: 1985-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HNR

view all

K022835 — STEPHENS DISPOSABLE FORCEPS2002-11-01
K895434 — ALCON FOLDING FORCEPS1989-12-04
K891487 — SOFT LENS FOLDING BLOCK1989-08-15
K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR1989-06-16
K885230 — MCDONALD FOLDING FORCEPS1989-05-17

More clearances from American Pharmaseal Div. Ahsc

view all

K874022 — PHARMASEAL WOUND IRRIGATION DEVICE1987-12-30
K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER1987-12-03
K874517 — PHARMASEAL RUBBER URETHRAL CATHETER1987-12-03
K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM1987-09-04

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.