The following data is part of a premarket notification filed by Pilling Co. with the FDA for No-scalpel Vascetomy Instruments.
Device ID | K922971 |
510k Number | K922971 |
Device Name: | NO-SCALPEL VASCETOMY INSTRUMENTS |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Richard G Jones |
Correspondent | Richard G Jones PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-19 |
Decision Date | 1992-09-23 |