HARKEN ASSURE SELF-SEAL STERILIZATION POUCH— 510(k) K945055

Substantially Equivalent

Harken Products, Inc.

FDA 510(k) clearance K945055 for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH, Substantially Equivalent on 1994-12-14. Applicant: Harken Products, Inc..

Clearance details

Applicant
Harken Products, Inc.
Product code
Code KCT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irwindall, CA, US
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