DR. FOG

Anti Fog Solution And Accessories, Endoscopy

O.R. CONCEPTS, INC.

The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Dr. Fog.

Pre-market Notification Details

• Device ID: K932449
• 510k Number: K932449
• Device Name: DR. FOG
• Classification: Anti Fog Solution And Accessories, Endoscopy
• Applicant: O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262
• Contact: John Mayall
• Correspondent: John Mayall; O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262
• Product Code: OCT
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-05-20
• Decision Date: 1993-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690521014633	K932449	000
00840113200580	K932449	000
00840113200603	K932449	000
00840113200870	K932449	000
00840113206902	K932449	000
00840113206957	K932449	000
00840113214099	K932449	000
00840113214822	K932449	000
00840113230433	K932449	000
20887761000036	K932449	000
10887761000053	K932449	000
20887761000067	K932449	000
10887761000077	K932449	000
10887761000084	K932449	000
50885380009028	K932449	000
20612479156948	K932449	000
00690521013728	K932449	000
40195327105366	K932449	000