The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Kensey Nash Dynamic Clip System.
Device ID | K923726 |
510k Number | K923726 |
Device Name: | KENSEY NASH DYNAMIC CLIP SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KENSEY NASH CORP. 55 EAST UWCHLAN AVE. MARSH CREEK CORP. CENTER Exton, PA 19341 -1247 |
Contact | Spriegel |
Correspondent | Spriegel KENSEY NASH CORP. 55 EAST UWCHLAN AVE. MARSH CREEK CORP. CENTER Exton, PA 19341 -1247 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1993-04-06 |