510(k) K802653

MEDIUM SIZE OXYGEN HOOD #1547 by Ann Arbor Plastics, Inc. — Product Code BYL

K802653 is an FDA 510(k) premarket notification submitted by Ann Arbor Plastics, Inc. for the device "MEDIUM SIZE OXYGEN HOOD #1547". The FDA issued a decision of Substantially Equivalent on November 24, 1980. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Ann Arbor Plastics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1980
Date Received
October 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Oxygen
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type