HEMATOME SYSTEM— 510(k) K885066

Substantially Equivalent

Surgical Dynamics, Inc.

FDA 510(k) clearance K885066 for HEMATOME SYSTEM, Substantially Equivalent on 1989-05-01. Applicant: Surgical Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Dynamics, Inc.
Product code: Code GET
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-12-06
Decision date: 1989-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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K931109 — NUCLEOTOME E KIT1994-03-29
K921950 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM1993-06-07

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