FDA 510(k) Application Details - K981922

Device Classification Name

  More FDA Info for this Device
510(K) Number K981922
Device Name LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
Applicant MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE, VA 22911 US
Other 510(k) Applications for this Company
Contact CARL ANGLES
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QPB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/01/1998
Decision Date 12/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact