510(k) K843693

JACOBS HIGH VACUUM SUCTION UNIT 05-2570 by J. Sklar Mfg. Co., Inc. — Product Code BTA

K843693 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "JACOBS HIGH VACUUM SUCTION UNIT 05-2570". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 19, 1984
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