The following data is part of a premarket notification filed by Innovative Surgical Devices Corp. with the FDA for Herniastat.
Device ID | K884404 |
510k Number | K884404 |
Device Name: | HERNIASTAT |
Classification | Stapler, Surgical |
Applicant | INNOVATIVE SURGICAL DEVICES CORP. 694 MAIN ST. Westbury, NY 11590 |
Contact | Robert R Oddsen |
Correspondent | Robert R Oddsen INNOVATIVE SURGICAL DEVICES CORP. 694 MAIN ST. Westbury, NY 11590 |
Product Code | GAG |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-19 |
Decision Date | 1988-11-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HERNIASTAT 74252910 not registered Dead/Abandoned |
Stryker Corporation 1992-03-06 |