510(k) K901362

ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE by Automatic Liquid Packaging, Inc. — Product Code CAF

K901362 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE". The FDA issued a decision of Substantially Equivalent on June 6, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
March 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type