SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC— 510(k) K900439

Name: FDA 510(k) clearance K900439
Creator: U.S. Food and Drug Administration
Published: 1990-02-15

Substantially Equivalent

L H M Ent., Inc.

FDA 510(k) clearance K900439 for SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC, Substantially Equivalent on 1990-02-15. Applicant: L H M Ent., Inc.. Device class: 2.

Clearance details

Applicant: L H M Ent., Inc.
Product code: Code FIH
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-29
Decision date: 1990-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Mills, NJ, US

Download summary PDF View on FDA.gov ↗

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