510(k) K071607
K071607 is an FDA 510(k) premarket notification submitted by Zhongshan A&J Medical Equipment Co., Ltd. for the device "ASA01 HEAVY DUTY SUCTION PUMP". The FDA issued a decision of Substantially Equivalent on June 26, 2007. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Zhongshan A&J Medical Equipment Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2007
- Date Received
- June 12, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type