The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Cadplan Bt.
Device ID | K954467 |
510k Number | K954467 |
Device Name: | CADPLAN BT |
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 | 1995-09-26 |
Decision Date | 1996-03-15 |
Summary: | summary |