The following data is part of a premarket notification filed by Surgiquip, Inc. with the FDA for Snap Reciprocating Saw.
Device ID | K935357 |
510k Number | K935357 |
Device Name: | SNAP RECIPROCATING SAW |
Classification | Spatula, Surgical, General & Plastic Surgery |
Applicant | SURGIQUIP, INC. 1799 E. 71ST ST. Tulsa, OK 74136 |
Contact | Mary Biggers |
Correspondent | Mary Biggers SURGIQUIP, INC. 1799 E. 71ST ST. Tulsa, OK 74136 |
Product Code | GAF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-04 |
Decision Date | 1994-01-28 |