DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

Syringe, Piston

EXEL INTL.

The following data is part of a premarket notification filed by Exel Intl. with the FDA for Disposable Syringes And Hypodermic Needles.

Pre-market Notification Details

• Device ID: K861153
• 510k Number: K861153
• Device Name: DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
• Classification: Syringe, Piston
• Applicant: EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194
• Contact: Eshagh Hamid
• Correspondent: Eshagh Hamid; EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-03-26
• Decision Date: 1986-04-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10020221664123	K861153	000
10020221660491	K861153	000
10020221660286	K861153	000
10020221664604	K861153	000
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