HYDROPREP GEL— 510(k) K964737

Substantially Equivalent

D.O. Weaver Co.

FDA 510(k) clearance K964737 for HYDROPREP GEL, Substantially Equivalent on 1997-03-19. Applicant: D.O. Weaver Co.. Device class: 2.

Clearance details

Applicant: D.O. Weaver Co.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1996-11-25
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, CO, US

Download summary PDF View on FDA.gov ↗

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