ORCEPAD— 510(k) K875123

Substantially Equivalent

Alton Dean Medical, Inc.

FDA 510(k) clearance K875123 for ORCEPAD, Substantially Equivalent on 1988-06-21. Applicant: Alton Dean Medical, Inc.. Device class: 2.

Clearance details

Applicant: Alton Dean Medical, Inc.
Product code: Code HDD
Device class: Class 2
Regulation: 21 CFR 884.4900
Advisory panel: Obstetrics/Gynecology
Date received: 1987-12-15
Decision date: 1988-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Salt Lake City, UT, 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.