DigniCap Scalp Cooling System— 510(k) K170871

Substantially Equivalent

Dignitana AB

FDA 510(k) clearance K170871 for DigniCap Scalp Cooling System, Substantially Equivalent on 2017-07-03. Applicant: Dignitana AB.

Clearance details

Applicant: Dignitana AB
Product code: Code PMC
Advisory panel: General, Plastic Surgery
Date received: 2017-03-23
Decision date: 2017-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

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