The following data is part of a premarket notification filed by Pilling Co. with the FDA for Clement-pilling Cholangiography Cath Guide/clamp.
Device ID | K914015 |
510k Number | K914015 |
Device Name: | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP |
Classification | Catheter, Cholangiography |
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 | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-09 |
Decision Date | 1991-11-21 |