RAPIDFLAP CRANIAL CLAMP


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K991029
Device Name RAPIDFLAP CRANIAL CLAMP
Applicant
WALTER LORENZ SURGICAL, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact diana preston
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact diana preston
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 03/29/1999
Decision Date 04/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No