The following data is part of a premarket notification filed by Pilling Co. with the FDA for Kaiser No Cannula Thoracoscopy/laparoscopy Instr.
Device ID | K925198 |
510k Number | K925198 |
Device Name: | KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1993-02-12 |