The following data is part of a premarket notification filed by American Safety Equipment Corp. with the FDA for Surgical Reciprocating Saw.
Device ID | K760957 |
510k Number | K760957 |
Device Name: | SURGICAL RECIPROCATING SAW |
Classification | Saw, Bone, Ac-powered |
Applicant | AMERICAN SAFETY EQUIPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DZH |
CFR Regulation Number | 872.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-01 |
Decision Date | 1976-11-15 |