MOLICARE

Garment, Protective, For Incontinence

PAUL HARTMANN CORP.

The following data is part of a premarket notification filed by Paul Hartmann Corp. with the FDA for Molicare.

Pre-market Notification Details

• Device ID: K843405
• 510k Number: K843405
• Device Name: MOLICARE
• Classification: Garment, Protective, For Incontinence
• Applicant: PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 -
• Contact: Robert L Crawford
• Correspondent: Robert L Crawford; PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 -
• Product Code: EYQ
• CFR Regulation Number: 876.5920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-08-30
• Decision Date: 1984-10-19