HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40

Sleeve, Limb, Compressible

HYGIA HEALTH SERVICES, INC.

The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Huntleigh Flowtron Dvt Sleeve Models Dvt10, Dvt 20, Dvt 30, Dvt 40.

Pre-market Notification Details

• Device ID: K012654
• 510k Number: K012654
• Device Name: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
• Classification: Sleeve, Limb, Compressible
• Applicant: HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211
• Contact: Geoff M Fatzinger
• Correspondent: Geoff M Fatzinger; HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-13
• Decision Date: 2002-04-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30817357021807	K012654	000
30817357021777	K012654	000
30817357021401	K012654	000
30817357021340	K012654	000
30817357020138	K012654	000