N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695

Respirator, Surgical

ALPHAPROTECH, INC.

The following data is part of a premarket notification filed by Alphaprotech, Inc. with the FDA for N95 Respirator Mask, Positive Facial Lock With Magic Arch, Model 695.

Pre-market Notification Details

• Device ID: K092824
• 510k Number: K092824
• Device Name: N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
• Classification: Respirator, Surgical
• Applicant: ALPHAPROTECH, INC. 236 NORTH 2200 WEST Salt Lake City, UT 84116
• Contact: David Kitchen
• Correspondent: David Kitchen; ALPHAPROTECH, INC. 236 NORTH 2200 WEST Salt Lake City, UT 84116
• Product Code: MSH
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-14
• Decision Date: 2009-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817583020141	K092824	000
20817583020134	K092824	000
20817583020127	K092824	000
10080196721719	K092824	000
10889950133696	K092824	000