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510(k) K883065

ALLOPREP SYSTEM by Osteotech, Inc. — Product Code KIT

K883065 is an FDA 510(k) premarket notification submitted by Osteotech, Inc. for the device "ALLOPREP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. Osteotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
July 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type

Other clearances by Osteotech, Inc.

  • K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT (October 16, 2008)
  • K081227 — PLEXUR M (July 22, 2008)
  • K080511 — PLEXUR-P (April 21, 2008)
  • K073405 — PLEXUR M (March 3, 2008)
  • K061982 — PLEXUR P (February 7, 2007)
  • K051188 — GRAFTON DBM (January 3, 2006)
  • K051781 — GRAFTCAGE TLX (December 16, 2005)
  • K051195 — GRAFTON DBM (December 16, 2005)
  • K043209 — VIAGRAF DBM PASTE (December 5, 2005)
  • K053080 — GRAFTCAGE ACX (December 1, 2005)

Other clearances for product code KIT

  • K892938 — AMNIO-GROW TM (May 22, 1989)
  • K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM) (February 24, 1989)
  • K890700 — MELANOCYTE GROWTH MEDIUM (MGM) (February 24, 1989)
  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)
  • K883951 — MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (September 30, 1988)

FDA data resources