MEDSPEC OPERATIVE OPTHALMIC KIT— 510(k) K800404

Substantially Equivalent

Medi-Spec

FDA 510(k) clearance K800404 for MEDSPEC OPERATIVE OPTHALMIC KIT, Substantially Equivalent on 1980-04-24. Applicant: Medi-Spec. Device class: 1.

Clearance details

Applicant: Medi-Spec
Product code: Code HMP
Device class: Class 1
Regulation: 21 CFR 878.4440
Advisory panel: General, Plastic Surgery
Date received: 1980-02-26
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMP

K940333 — EYE PAD1994-03-07
K921349 — STERILE,DISPOSABLE EYE DRESSING1992-05-29
K904896 — EYE PAD1990-12-05
K883822 — FIRST AID KIT, EYE DRESSING NSN6545-00-853-63091988-11-22
K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK'1988-01-27

More clearances from Medi-Spec

K833068 — LAMINARIA JAPONICA CERVICAL DILATOR1984-02-04
K812694 — WHISK-R1981-10-26
K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX)1981-10-08
K801554 — STERILE CAST PADDING1980-08-04
K800490 — STERILE DRESSING PACK1980-03-12

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