The following data is part of a premarket notification filed by Tower Mfg. Co., Inc. with the FDA for Additions To Wsl Nitrospray Cryosurgical Units.
Device ID | K872796 |
510k Number | K872796 |
Device Name: | ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS |
Classification | Unit, Cryosurgical, Accessories |
Applicant | TOWER MFG. CO., INC. P.O. BOX 32336 NIMITZ STATION San Antonio, TX 78216 |
Contact | F. M Sandlin |
Correspondent | F. M Sandlin TOWER MFG. CO., INC. P.O. BOX 32336 NIMITZ STATION San Antonio, TX 78216 |
Product Code | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-07-23 |