The following data is part of a premarket notification filed by Kck Industries with the FDA for Kck Industries' Surgical Instruments.
Device ID | K871894 |
510k Number | K871894 |
Device Name: | KCK INDUSTRIES' SURGICAL INSTRUMENTS |
Classification | Scalpel, One-piece |
Applicant | KCK INDUSTRIES 4613 ROMBERS PLACE Woodland Hills, CA 91364 |
Contact | Bruce R Sather |
Correspondent | Bruce R Sather KCK INDUSTRIES 4613 ROMBERS PLACE Woodland Hills, CA 91364 |
Product Code | GDX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-01 |
Decision Date | 1987-06-23 |