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 |