510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HKCClass I

Spectacle Microscope, Low-Vision

21 CFR 886.5540 / Ophthalmic
FDA source (opens on fda.gov)

HKC is the FDA product code for Spectacle Microscope, Low-Vision, a class I device type, regulated under 21 CFR 886.5540. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HKC
Device name
Spectacle Microscope, Low-Vision
Regulation
21 CFR 886.5540
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code HKC

By decision year
1 clearance under product code HKC with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HKC by decision year
YearClearances
19831

Applicants with the most clearances

Product code HKC
Applicants holding the most 510(k) clearances under product code HKC
ApplicantClearances
Almore Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code