The following data is part of a premarket notification filed by Pilling Co. with the FDA for Tibial Artery Clamp W/atraugrip Jaws.
Device ID | K760648 |
510k Number | K760648 |
Device Name: | TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | PILLING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-15 |
Decision Date | 1976-09-21 |