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FDA Product Code

FDA Product Code HOE — Clearance Directory

Device Class
Class I
Assigned Panel
Ophthalmic
21 CFR Citation
886.4350

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K881094 KOI(TM) BLADE GAUGE, MODEL KOI-132 CooperVision, Inc. 1988-04-01 Traditional PDF ↗
K813315 CALIPER-OPTHALMIC Design Research Assoc., Inc. 1982-03-01 Traditional PDF ↗
K820050 KREMER BLADE GAUGE Accutome, Inc. 1982-02-24 Traditional PDF ↗
K812011 BLADE GAUGE Koi, Inc. 1981-07-28 Traditional PDF ↗
K801937 BLEPHAROMETER Aztec Medical Products, Inc. 1980-09-16 Traditional PDF ↗
K792383 KELMAN DIPSTICK V. Mueller O.V. Baxter Healthcare Corp. 1979-12-11 Traditional PDF ↗
K781715 RULER, WECK SCOTT Edward Weck, Inc. 1978-12-04 Traditional PDF ↗

Product code HOE · Class I · Ophthalmic. Data: openFDA.