The following data is part of a premarket notification filed by Cryosurgery, Inc. with the FDA for Verruca-freeze Cryosurgical Delivery System (modification).
Device ID | K955083 |
510k Number | K955083 |
Device Name: | VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) |
Classification | Unit, Cryosurgical, Accessories |
Applicant | CRYOSURGERY, INC. P.O.BOX 50035 Nashville, TN 37205 -0035 |
Contact | Ronald A Mcdow |
Correspondent | Ronald A Mcdow CRYOSURGERY, INC. P.O.BOX 50035 Nashville, TN 37205 -0035 |
Product Code | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-25 |
Decision Date | 1996-02-08 |