The following data is part of a premarket notification filed by Orthopedic Technology, Inc. with the FDA for Ortho Tech Cryologic System.
| Device ID | K940429 |
| 510k Number | K940429 |
| Device Name: | ORTHO TECH CRYOLOGIC SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | ORTHOPEDIC TECHNOLOGY, INC. 1905 N. MACARTHUR DR. Tracy, CA 95376 |
| Contact | Calvin Andre |
| Correspondent | Calvin Andre ORTHOPEDIC TECHNOLOGY, INC. 1905 N. MACARTHUR DR. Tracy, CA 95376 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1994-07-12 |