Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970885
Device Classification Name
Cover, Barrier, Protective
More FDA Info for this Device
510(K) Number
K970885
Device Name
Cover, Barrier, Protective
Applicant
PROTEK MEDICAL PRODUCTS, INC.
221 E. MARKET ST. SUITE 291
IOWA CITY, IA 52245 US
Other 510(k) Applications for this Company
Contact
RICK L PRUTER
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
MMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/1997
Decision Date
09/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact