The following data is part of a premarket notification filed by Cryosurgery, Inc. with the FDA for Verruca-freeze Cryosurgery Delivery System.
| Device ID | K982506 |
| 510k Number | K982506 |
| Device Name: | VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM |
| 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 | 1998-07-20 |
| Decision Date | 1999-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865715000383 | K982506 | 000 |
| 00865715000376 | K982506 | 000 |
| 00865715000390 | K982506 | 000 |
| 00865715000307 | K982506 | 000 |
| 00865715000314 | K982506 | 000 |
| 00865715000321 | K982506 | 000 |
| 00865715000338 | K982506 | 000 |
| 00865715000345 | K982506 | 000 |
| 00865715000352 | K982506 | 000 |
| 00865715000369 | K982506 | 000 |