The following data is part of a premarket notification filed by Rocket Of London, Ltd. with the FDA for Suture Removing Forceps.
Device ID | K932385 |
510k Number | K932385 |
Device Name: | SUTURE REMOVING FORCEPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
Contact | Todd |
Correspondent | Todd ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-17 |
Decision Date | 1993-08-06 |