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510(k) K860511

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

K860511 is an FDA 510(k) premarket notification submitted by Ammerman Medical Enterprises, Inc. for the device "AMPU-PAK". The FDA issued a decision of Substantially Equivalent on August 4, 1986. The device falls under product code LPZ (Container, Frozen Donor Tissue Storage), a Class U device.

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

Other clearances for product code LPZ

  • K021702 — CRYOBAG, MODEL CB (August 6, 2002)
  • K915471 — CRYOBAG (March 2, 1994)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K861761 — ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (August 28, 1986)
  • K853663 — ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (April 9, 1986)

FDA data resources