PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE

Dressing, Wound, Drug

PRUGEN IP HOLDINGS, INC

The following data is part of a premarket notification filed by Prugen Ip Holdings, Inc with the FDA for Prutect Topical Ointment, Models 45 Gram Tube, 90 Gram Tube.

Pre-market Notification Details

• Device ID: K092878
• 510k Number: K092878
• Device Name: PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
• Classification: Dressing, Wound, Drug
• Applicant: PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255
• Contact: Robert L Knechtel
• Correspondent: Robert L Knechtel; PRUGEN IP HOLDINGS, INC 8711 E PINNACLE PEAK ROAD SUITE C-201, PMB 225 Scottsdale, AZ 85255
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-18
• Decision Date: 2010-01-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860003521205	K092878	000