510(k) K973671
K973671 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ENDOCERVICAL BLOCK NEEDLE". The FDA issued a decision of Substantially Equivalent on November 26, 1997. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1997
- Date Received
- September 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Anesthesia, Paracervical
- Device Class
- Class II
- Regulation Number
- 884.5100
- Review Panel
- OB
- Submission Type