The following data is part of a premarket notification filed by Enterprise Medical Corp. with the FDA for Kerrison Rongeurs.
Device ID | K943583 |
510k Number | K943583 |
Device Name: | KERRISON RONGEURS |
Classification | Rongeur, Manual |
Applicant | ENTERPRISE MEDICAL CORP. 3214 BRASSFIELD RD., #2201 Greensboro, NC 27410 |
Contact | Reuben Margoliash |
Correspondent | Reuben Margoliash ENTERPRISE MEDICAL CORP. 3214 BRASSFIELD RD., #2201 Greensboro, NC 27410 |
Product Code | HAE |
CFR Regulation Number | 882.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-22 |
Decision Date | 1995-02-21 |