CRYOLYZER ALPHA (CRYOSURG.EQUIP.)

Unit, Cryosurgical, Accessories

CRYO-LABS, INC.

The following data is part of a premarket notification filed by Cryo-labs, Inc. with the FDA for Cryolyzer Alpha (cryosurg.equip.).

Pre-market Notification Details

Device IDK760686
510k NumberK760686
Device Name:CRYOLYZER ALPHA (CRYOSURG.EQUIP.)
ClassificationUnit, Cryosurgical, Accessories
Applicant CRYO-LABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-09-20
Decision Date1976-11-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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