Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K972860
Device Classification Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
More FDA Info for this Device
510(K) Number
K972860
Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Applicant
BIOLECTRON, INC.
200 HOLT ST.
HACKENSACK, NJ 07601 US
Other 510(k) Applications for this Company
Contact
RICHARD S DUGOT
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
HSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/1997
Decision Date
10/31/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact