The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Sawblade.
Device ID | K863788 |
510k Number | K863788 |
Device Name: | SAWBLADE |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Contact | Terry M Mattchen |
Correspondent | Terry M Mattchen TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-26 |
Decision Date | 1986-10-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887919985815 | K863788 | 000 |
00887919985785 | K863788 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAWBLADE 78086747 2730726 Live/Registered |
ROCKY BRANDS, INC. 2001-10-03 |
SAWBLADE 77122958 not registered Dead/Abandoned |
Lubean, Whitney Jacob 2007-03-06 |