The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Snap Pak(tm), Modification.
Device ID | K915081 |
510k Number | K915081 |
Device Name: | MITEK SNAP PAK(TM), MODIFICATION |
Classification | Suture, Nonabsorbable, Synthetic, Polyester |
Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Contact | Robert P Zoletti |
Correspondent | Robert P Zoletti MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
Product Code | GAS |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-12 |
Decision Date | 1992-01-31 |