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510(k) K860511

AMPU-PAK by Ammerman Medical Enterprises, Inc. — Product Code LPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1986
Date Received
February 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Frozen Donor Tissue Storage
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type

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  • K861761 — ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (August 28, 1986)
  • K853663 — ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (April 9, 1986)