510(k) K930615
K930615 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "AUTOVAC CLOSED WOUND SUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Boehringer Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1994
- Date Received
- February 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device Class
- Class I
- Regulation Number
- 878.4680
- Review Panel
- SU
- Submission Type