The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Micro Forceps.
Device ID | K834355 |
510k Number | K834355 |
Device Name: | MICRO FORCEPS |
Classification | Forceps, Ophthalmic |
Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-13 |
Decision Date | 1984-03-16 |