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BALLERT CRANIAL MOLDING HELMET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011433
510(k) Type
Traditional
Applicant
GEMA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2001
Days to Decision
33 days
Submission Type
Statement

BALLERT CRANIAL MOLDING HELMET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011433
510(k) Type
Traditional
Applicant
GEMA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/12/2001
Days to Decision
33 days
Submission Type
Statement