510(k) K973671

ENDOCERVICAL BLOCK NEEDLE by A & A Medical, Inc. — Product Code HEE

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