510(k) K913275

VENTURI OXYGEN MASK by Specialty Packaging Producs, Inc. — Product Code BYG

K913275 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "VENTURI OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
July 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type