SHARPS-TAINER

Needle, Hypodermic, Single Lumen

WINFIELD INDUSTRIES

The following data is part of a premarket notification filed by Winfield Industries with the FDA for Sharps-tainer.

Pre-market Notification Details

• Device ID: K942054
• 510k Number: K942054
• Device Name: SHARPS-TAINER
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: WINFIELD INDUSTRIES 9750 DISTRIBUTION AVE. San Diego, CA 92121
• Contact: David Olmstead
• Correspondent: David Olmstead; WINFIELD INDUSTRIES 9750 DISTRIBUTION AVE. San Diego, CA 92121
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-28
• Decision Date: 1994-08-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H362186S2	K942054	000
H362178V2	K942054	000
H362178TY2	K942054	000
H3621782	K942054	000
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H362185S2	K942054	000
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H3621992	K942054	000
H36219502	K942054	000
H3621952	K942054	000
H362187V2	K942054	000
H362187S2	K942054	000
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H362CN41852	K942054	000
H36297522	K942054	000
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H3629322	K942054	000
H362931W2	K942054	000
H3629302	K942054	000
H362186WV2	K942054	000