The following data is part of a premarket notification filed by Best Industries with the FDA for Implant Applicators, Cartridges/magazines, Implanters For Permanent Implant Of Radioactive Seeds/sources.
Device ID | K933410 |
510k Number | K933410 |
Device Name: | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES |
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 | 1993-07-15 |
Decision Date | 1994-12-30 |