The following data is part of a premarket notification filed by Pilling Co. with the FDA for Micro Anastomosis Clamp.
Device ID | K861924 |
510k Number | K861924 |
Device Name: | MICRO ANASTOMOSIS CLAMP |
Classification | Clamp, Vascular |
Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Leland J Wimer |
Correspondent | Leland J Wimer PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-19 |
Decision Date | 1986-06-06 |