Atlas FDA

HJH

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Loupe, Binocular, Low Power
Device class
Class I (low risk)
Regulation
21 CFR 886.5120
Medical specialty
Ophthalmic
Flags
GMP exempt
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RecordFirmDate
MALIS SURGICAL LOUPES (K874845)Valley Forge Scientific Corp.1987-12-23
EXETER OPERATING LOUPE (K863983)Exeter Instruments, Inc.1986-11-10
BINOCULAR LOUPE (K830878)Almore Intl., Inc.1983-04-06

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