The following data is part of a premarket notification filed by Martin S. Knopf Assoc., Inc. with the FDA for Uram Ophthalmic Laser Endoscope.
Device ID | K910532 |
510k Number | K910532 |
Device Name: | URAM OPHTHALMIC LASER ENDOSCOPE |
Classification | Laser, Ophthalmic |
Applicant | MARTIN S. KNOPF ASSOC., INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
Contact | Martin S Knopf |
Correspondent | Martin S Knopf MARTIN S. KNOPF ASSOC., INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-08 |
Decision Date | 1991-05-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30886158016251 | K910532 | 000 |
30886158016114 | K910532 | 000 |
30886158016107 | K910532 | 000 |
30886158016091 | K910532 | 000 |
30886158016084 | K910532 | 000 |
30886158016077 | K910532 | 000 |
30886158016060 | K910532 | 000 |
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 |
30886158016190 | K910532 | 000 |
30886158016183 | K910532 | 000 |
30886158016176 | K910532 | 000 |
30886158016169 | K910532 | 000 |
30886158016152 | K910532 | 000 |
30886158016015 | K910532 | 000 |