SURG-K SURGICAL KERATOMETER— 510(k) K901553

Substantially Equivalent

The Sanborn Co.

FDA 510(k) clearance K901553 for SURG-K SURGICAL KERATOMETER, Substantially Equivalent on 1990-07-20. Applicant: The Sanborn Co.. Device class: 1.

Clearance details

Applicant: The Sanborn Co.
Product code: Code HLR
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1990-04-03
Decision date: 1990-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLR

K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE1988-08-04
K882618 — JEDMED/POLACK KERATOSCOPE HS/SL1988-07-13
K864639 — REUSABLE SURGICAL KERATOSCOPE1986-12-29
K854054 — PLACIDO DISC1985-12-27
K830008 — KARICKHOFF KERATOSCOPE1983-01-26

More clearances from The Sanborn Co.

K901523 — VKG 1000, VIDEO KERATOGRAPH1990-06-27

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