The following data is part of a premarket notification filed by Cryotherapy Products Inc. with the FDA for Cold Pack, Plastic Applicator (medical Grade)-non-chemical.
| Device ID | K113660 |
| 510k Number | K113660 |
| Device Name: | COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | CRYOTHERAPY PRODUCTS INC. 1804 SW 81 Terrace Davie, FL 33324 |
| Contact | Jorge Caballero |
| Correspondent | Jorge Caballero CRYOTHERAPY PRODUCTS INC. 1804 SW 81 Terrace Davie, FL 33324 |
| Product Code | LKX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-05-03 |