STASIS BUTTON PRSSURE DEVICE— 510(k) K912765

Name: FDA 510(k) clearance K912765
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Arch Development Group

FDA 510(k) clearance K912765 for STASIS BUTTON PRSSURE DEVICE, Substantially Equivalent on 1991-08-12. Applicant: Arch Development Group. Device class: 1.

Clearance details

Applicant: Arch Development Group
Product code: Code MHW
Device class: Class 1
Regulation: 21 CFR 880.5075
Advisory panel: General Hospital
Date received: 1991-06-24
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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