ALLOPREP SYSTEM— 510(k) K883065

Substantially Equivalent

Osteotech, Inc.

FDA 510(k) clearance K883065 for ALLOPREP SYSTEM, Substantially Equivalent on 1988-10-13. Applicant: Osteotech, Inc.. Device class: 1.

Clearance details

Applicant: Osteotech, Inc.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1988-07-20
Decision date: 1988-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shrewsbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIT

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K890482 — ABC, ABC-1X, ABC(TM)1989-02-10
K884654 — ALPHACALF SERUM1988-11-30

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K081227 — PLEXUR M2008-07-22
K080511 — PLEXUR-P2008-04-21
K073405 — PLEXUR M2008-03-03
K061982 — PLEXUR P2007-02-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.