UNKNOWN

Syringe, Piston

GELMAN SCIENCES, INC.

The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Unknown.

Pre-market Notification Details

• Device ID: K941032
• 510k Number: K941032
• Device Name: UNKNOWN
• Classification: Syringe, Piston
• Applicant: GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019
• Contact: Mitchell L Ehrlich
• Correspondent: Mitchell L Ehrlich; GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019
• Product Code: FMF
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-07
• Decision Date: 1994-05-27