The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Scissors, Iris.
Device ID | K770019 |
510k Number | K770019 |
Device Name: | SCISSORS, IRIS |
Classification | Scissors, Ophthalmic |
Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNF |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-01-05 |
Decision Date | 1977-01-12 |