AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE

Filter, Bacterial, Breathing-circuit

AMERICAN PHARMASEAL DIV. AHSC

The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for American Twa Way Filter -bacterial/viral-retentive.

Pre-market Notification Details

• Device ID: K850265
• 510k Number: K850265
• Device Name: AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209
• Contact: Lawrence W Gettlin
• Correspondent: Lawrence W Gettlin; AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-01-23
• Decision Date: 1985-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30889483570764	K850265	000
30889483570740	K850265	000