The following data is part of a premarket notification filed by Best Industries with the FDA for Royal Marsden Gold Grain Gun.
Device ID | K940119 |
510k Number | K940119 |
Device Name: | ROYAL MARSDEN GOLD GRAIN GUN |
Classification | Shield, Eye, Radiological |
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 | IWS |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-10 |
Decision Date | 1994-12-30 |