CryoTouch

Unit, Cryosurgical, Accessories

CryoConcepts LP

The following data is part of a premarket notification filed by Cryoconcepts Lp with the FDA for Cryotouch.

Pre-market Notification Details

• Device ID: K183601
• 510k Number: K183601
• Device Name: CryoTouch
• Classification: Unit, Cryosurgical, Accessories
• Applicant: CryoConcepts LP 205 Webster Street Bethlehem, PA 18015
• Contact: Sam Niedbala
• Correspondent: Sam Niedbala; CryoConcepts LP 205 Webster Street Bethlehem, PA 18015
• Product Code: GEH
• CFR Regulation Number: 878.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-26
• Decision Date: 2019-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850077006371	K183601	000
00850077006401	K183601	000
00850077006395	K183601	000
00850077006388	K183601	000