510(k) K870094

BUNN MODEL 530 ASPIRATOR by The John Bunn Co. — Product Code BTA

K870094 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN MODEL 530 ASPIRATOR". The FDA issued a decision of Substantially Equivalent on March 6, 1987. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1987
Date Received
January 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type