PROTIME MICROCOAGULATION SYSTEM— 510(k) K951072

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K951072 for PROTIME MICROCOAGULATION SYSTEM, Substantially Equivalent on 1995-10-27. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant
International Technidyne Corp.
Product code
Code GKP
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edison, NJ, US
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