AMMOCENTESIS TRAY (KIT)— 510(k) K761230

Name: FDA 510(k) clearance K761230
Creator: U.S. Food and Drug Administration
Published: 1976-12-17

Substantially Equivalent

Pharmaseal Div., Baxter Healthcare Corp.

FDA 510(k) clearance K761230 for AMMOCENTESIS TRAY (KIT), Substantially Equivalent on 1976-12-17. Applicant: Pharmaseal Div., Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Pharmaseal Div., Baxter Healthcare Corp.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1976-12-10
Decision date: 1976-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K921738 — SONO-VU US(TM), MODIFICATION1992-04-27

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