MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE

Needle, Hypodermic, Single Lumen

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sterile M200 Aluminum/m250 Polypropylene.

Pre-market Notification Details

• Device ID: K854547
• 510k Number: K854547
• Device Name: MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625
• Contact: Frank J Fucile
• Correspondent: Frank J Fucile; SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-13
• Decision Date: 1986-02-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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