The following data is part of a premarket notification filed by Incon Diversified Industries, Inc. with the FDA for Splash Mask.
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756564224 | K941932 | 000 |
| 00612479268913 | K941932 | 000 |
| 00612479268883 | K941932 | 000 |
| 00612479268852 | K941932 | 000 |
| 00612479268821 | K941932 | 000 |
| 00612479270404 | K941932 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPLASH MASK 87191331 5204366 Live/Registered |
Aramara Beauty llc 2016-10-03 |
![]() SPLASH MASK 85037684 3858600 Live/Registered |
Encompass Group, LLC 2010-05-13 |
![]() SPLASH MASK 78536225 not registered Dead/Abandoned |
Embrace Healthcare, LLC 2004-12-21 |