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MEDTEXX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963331
510(k) Type
Traditional
Applicant
REGALFIELD SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
1/24/1997
Days to Decision
154 days
Submission Type
Statement

MEDTEXX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963331
510(k) Type
Traditional
Applicant
REGALFIELD SDN. BHD.
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
1/24/1997
Days to Decision
154 days
Submission Type
Statement