The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Absorbalbe Anchor.
Device ID | K944051 |
510k Number | K944051 |
Device Name: | ABSORBALBE ANCHOR |
Classification | Strip, Dialysate Ph Indicator |
Applicant | MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
Contact | Edward F Kent |
Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
Product Code | MNV |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-19 |
Decision Date | 1995-08-02 |