The following data is part of a premarket notification filed by Cryo-labs, Inc. with the FDA for Cryolyzer Alpha (cryosurg.equip.).
| Device ID | K760686 |
| 510k Number | K760686 |
| Device Name: | CRYOLYZER ALPHA (CRYOSURG.EQUIP.) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYO-LABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-20 |
| Decision Date | 1976-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850510007580 | K760686 | 000 |
| 10850510007474 | K760686 | 000 |
| 10850510007481 | K760686 | 000 |
| 10850510007498 | K760686 | 000 |
| 10850510007504 | K760686 | 000 |
| 10850510007511 | K760686 | 000 |
| 10850510007528 | K760686 | 000 |
| 10850510007535 | K760686 | 000 |
| 10850510007542 | K760686 | 000 |
| 10850510007559 | K760686 | 000 |
| 10850510007566 | K760686 | 000 |
| 10850510007573 | K760686 | 000 |
| 10850510007467 | K760686 | 000 |