The following data is part of a premarket notification filed by Best Industries with the FDA for Various Template Applicators.
Device ID | K910862 |
510k Number | K910862 |
Device Name: | VARIOUS TEMPLATE APPLICATORS |
Classification | System, Applicator, Radionuclide, Manual |
Applicant | BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
Contact | Sankara I Ramaswamy |
Correspondent | Sankara I Ramaswamy BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
Product Code | IWJ |
CFR Regulation Number | 892.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-01 |
Decision Date | 1991-04-18 |