510(k) K843693
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 Oct 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 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 1984
- Date Received
- Sep 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
- 510(k)