The following data is part of a premarket notification filed by Pilling Co. with the FDA for Abdominal/vascular Retractor-split Wishbone 163000.
Device ID | K874243 |
510k Number | K874243 |
Device Name: | ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 |
Classification | Retractor |
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 | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-16 |
Decision Date | 1987-11-13 |