URAM OPHTHALMIC LASER ENDOSCOPE

Laser, Ophthalmic

MARTIN S. KNOPF ASSOC., INC.

The following data is part of a premarket notification filed by Martin S. Knopf Assoc., Inc. with the FDA for Uram Ophthalmic Laser Endoscope.

Pre-market Notification Details

Device IDK910532
510k NumberK910532
Device Name:URAM OPHTHALMIC LASER ENDOSCOPE
ClassificationLaser, Ophthalmic
Applicant MARTIN S. KNOPF ASSOC., INC. 28 MARIGOLD LN. Marlboro,  NJ  07746
ContactMartin S Knopf
CorrespondentMartin S Knopf
MARTIN S. KNOPF ASSOC., INC. 28 MARIGOLD LN. Marlboro,  NJ  07746
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-08
Decision Date1991-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30886158016251 K910532 000
30886158016114 K910532 000
30886158016107 K910532 000
30886158016091 K910532 000
30886158016084 K910532 000
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30886158016053 K910532 000
30886158016046 K910532 000
30886158016039 K910532 000
30886158016022 K910532 000
30886158016121 K910532 000
30886158016138 K910532 000
30886158016145 K910532 000
30886158016244 K910532 000
30886158016237 K910532 000
30886158016220 K910532 000
30886158016213 K910532 000
30886158016206 K910532 000
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30886158016183 K910532 000
30886158016176 K910532 000
30886158016169 K910532 000
30886158016152 K910532 000
30886158016015 K910532 000

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