The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Thorek Scissors 7 1/4 & 10.
Device ID | K771806 |
510k Number | K771806 |
Device Name: | THOREK SCISSORS 7 1/4 & 10 |
Classification | Cutter, Surgical |
Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FZT |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-23 |
Decision Date | 1977-10-04 |