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510(k) K915471

CRYOBAG by Janus Biomedical, Inc. — Product Code LPZ

K915471 is an FDA 510(k) premarket notification submitted by Janus Biomedical, Inc. for the device "CRYOBAG". The FDA issued a decision of Substantially Equivalent on March 2, 1994. The device falls under product code LPZ (Container, Frozen Donor Tissue Storage), a Class U device. Janus Biomedical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1994
Date Received
December 6, 1991
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 by Janus Biomedical, Inc.

  • K943803 — JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (January 30, 1996)

Other clearances for product code LPZ

  • K021702 — CRYOBAG, MODEL CB (August 6, 2002)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K861761 — ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (August 28, 1986)
  • K860511 — AMPU-PAK (August 4, 1986)
  • K853663 — ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (April 9, 1986)

FDA data resources