SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200

Apparatus, Exhaust, Surgical

SUN MEDICAL, INC.

The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Sun Medical Smoke/fluid Evac Syst, Model Sfe-200.

Pre-market Notification Details

• Device ID: K911154
• 510k Number: K911154
• Device Name: SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
• Classification: Apparatus, Exhaust, Surgical
• Applicant: SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006
• Contact: Howard Penney
• Correspondent: Howard Penney; SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST SUITE 100 Arlington, TX 76006
• Product Code: FYD
• CFR Regulation Number: 878.5070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-15
• Decision Date: 1991-07-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B22691200000	K911154	000
B22687300001	K911154	000
B22687300000	K911154	000