The following data is part of a premarket notification filed by Y.m.k. International Co., Ltd. with the FDA for Disposable Surgical Scissors And Forceps.
Device ID | K943229 |
510k Number | K943229 |
Device Name: | DISPOSABLE SURGICAL SCISSORS AND FORCEPS |
Classification | Instrument, Surgical, Disposable |
Applicant | Y.M.K. INTERNATIONAL CO., LTD. 3F 2LN 200 SEC. 4, CHENGKUNG RD. Taipei, TW |
Contact | Y. M Kung |
Correspondent | Y. M Kung Y.M.K. INTERNATIONAL CO., LTD. 3F 2LN 200 SEC. 4, CHENGKUNG RD. Taipei, TW |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-06 |
Decision Date | 1994-08-19 |