PATIENT CONTOURED MESH-PEEK (PCM-P)


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K072707
Device Name PATIENT CONTOURED MESH-PEEK (PCM-P)
Applicant
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Applicant Contact jennifer damato
Correspondent
KLS-MARTIN L.P.
11239-1 st. john’s ind. pkwy.
south
jacksonville, 
FL 
32246

Correspodent Contact jennifer damato
Regulation Number 882.5330
Classification Product Code
GXN  
Subsequent Product Code
GXP  
Date Received 09/25/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No