MACMED PAEDIATRIC INTRAMEDULLARY NAIL


Device Classification Name

nail, fixation, bone

510(k) Number K991877
Device Name MACMED PAEDIATRIC INTRAMEDULLARY NAIL
Applicant
INNERVISION, INC.
6258 shady grove rd. e.
memphis, 
TN 
38120

Applicant Contact frank m lewis
Correspondent
INNERVISION, INC.
6258 shady grove rd. e.
memphis, 
TN 
38120

Correspodent Contact frank m lewis
Regulation Number 888.3030
Classification Product Code
JDS  
Date Received 06/02/1999
Decision Date 08/06/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No