510(k) K934011
K934011 is an FDA 510(k) premarket notification submitted by Neward Enterprises, Inc. for the device "MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE". The FDA issued a decision of Substantially Equivalent on May 4, 1994. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Neward Enterprises, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 1994
- Date Received
- August 17, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractor, Vacuum, Fetal
- Device Class
- Class II
- Regulation Number
- 884.4340
- Review Panel
- OB
- Submission Type