The following data is part of a premarket notification filed by Precision-cosmet Co., Inc. with the FDA for Manual Ophthalmic Surgical Instruments.
Device ID | K861057 |
510k Number | K861057 |
Device Name: | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS |
Classification | Forceps, Ophthalmic |
Applicant | PRECISION-COSMET CO., INC. 11140 BREN RD. W. Minnetonka, MN 55343 |
Contact | Robert L Ullen |
Correspondent | Robert L Ullen PRECISION-COSMET CO., INC. 11140 BREN RD. W. Minnetonka, MN 55343 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-19 |
Decision Date | 1986-04-24 |