The following data is part of a premarket notification filed by Dermatologic Lab & Supply, Inc. with the FDA for Frigiderm Frigispray.
| Device ID | K971216 |
| 510k Number | K971216 |
| Device Name: | FRIGIDERM FRIGISPRAY |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | DERMATOLOGIC LAB & SUPPLY, INC. 608 13TH AVE. Council Bluffs, IA 51501 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky DERMATOLOGIC LAB & SUPPLY, INC. 608 13TH AVE. Council Bluffs, IA 51501 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-05-29 |
| Summary: | summary |