The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Cks Oscillating Saw Blade.
Device ID | K921131 |
510k Number | K921131 |
Device Name: | CKS OSCILLATING SAW BLADE |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
Contact | David Samson |
Correspondent | David Samson TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-10 |
Decision Date | 1992-06-08 |