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510(k) K863872

TAMPER HAMPER by Hydro-Med Products, Inc. — Product Code LPZ

K863872 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "TAMPER HAMPER". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code LPZ (Container, Frozen Donor Tissue Storage), a Class U device. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
October 3, 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 by Hydro-Med Products, Inc.

  • K944198 — SURGICAL MICROSCOPE DRAPE (November 27, 1994)
  • K940151 — ULTRASOUND PROBE DRAPE (November 14, 1994)
  • K934630 — UNIVERSAL VIDEO/LASER ARM DRAPE (October 28, 1994)
  • K940152 — CAMERA COVER WITH TEAR TIP (October 28, 1994)
  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K853281 — EASYTOP (August 21, 1985)
  • K842304 — THE PATHFINDER (August 1, 1984)
  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)
  • K790659 — INFANT SCALE DISPOSABLE LINER (April 30, 1979)

Other clearances for product code LPZ

  • K021702 — CRYOBAG, MODEL CB (August 6, 2002)
  • K915471 — CRYOBAG (March 2, 1994)
  • 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