The following data is part of a premarket notification filed by Csa Medical, Inc. with the FDA for Trufreeze System, Trufreeze Spray Kit.
| Device ID | K113021 |
| 510k Number | K113021 |
| Device Name: | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CSA MEDICAL, INC. 1447 York Rd Ste 610 Lutherville, MD 21093 |
| Contact | Colleen Kistler |
| Correspondent | Colleen Kistler CSA MEDICAL, INC. 1447 York Rd Ste 610 Lutherville, MD 21093 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857068006112 | K113021 | 000 |
| 10857068006034 | K113021 | 000 |
| 10857068006027 | K113021 | 000 |
| 10857068006010 | K113021 | 000 |
| 10857068006072 | K113021 | 000 |
| 10724995199330 | K113021 | 000 |
| 10724995199323 | K113021 | 000 |
| 10724995199286 | K113021 | 000 |
| 10724995199224 | K113021 | 000 |
| 10724995199217 | K113021 | 000 |
| 10857068006102 | K113021 | 000 |
| 10857068006119 | K113021 | 000 |
| 00857068006105 | K113021 | 000 |
| 00857068006099 | K113021 | 000 |
| 00857068006082 | K113021 | 000 |
| 00857068006075 | K113021 | 000 |
| 00857068006044 | K113021 | 000 |
| 00857068006037 | K113021 | 000 |
| 00857068006020 | K113021 | 000 |
| 00857068006013 | K113021 | 000 |
| 00857068006006 | K113021 | 000 |
| 10724995199200 | K113021 | 000 |