CAREPAK

Nebulizer (direct Patient Interface)

PRECISION MEDICAL, INC.

The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Carepak.

Pre-market Notification Details

• Device ID: K942350
• 510k Number: K942350
• Device Name: CAREPAK
• Classification: Nebulizer (direct Patient Interface)
• Applicant: PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067
• Contact: Conley Wallace
• Correspondent: Conley Wallace; PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-17
• Decision Date: 1994-12-06