SPLASH MASK

Accessory, Surgical Apparel

INCON DIVERSIFIED INDUSTRIES, INC.

The following data is part of a premarket notification filed by Incon Diversified Industries, Inc. with the FDA for Splash Mask.

Pre-market Notification Details

• Device ID: K941932
• 510k Number: K941932
• Device Name: SPLASH MASK
• Classification: Accessory, Surgical Apparel
• Applicant: INCON DIVERSIFIED INDUSTRIES, INC. 5 FLAGSTONE DR. Hudson, NH 03051
• Contact: Robert J Butler
• Correspondent: Robert J Butler; INCON DIVERSIFIED INDUSTRIES, INC. 5 FLAGSTONE DR. Hudson, NH 03051
• Product Code: LYU
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-20
• Decision Date: 1994-07-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50749756564224	K941932	000