The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Applicators For Varian Varisource Remote High Soes Rate Afterloader.
| Device ID | K952913 | 
| 510k Number | K952913 | 
| Device Name: | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER | 
| Classification | System, Applicator, Radionuclide, Remote-controlled | 
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 | 
| Contact | Charles H Will | 
| Correspondent | Charles H Will VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 | 
| Product Code | JAQ | 
| CFR Regulation Number | 892.5700 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1995-06-26 | 
| Decision Date | 1995-11-22 |