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GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K965044
510(k) Type
Traditional
Applicant
ELSCINT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/1997
Days to Decision
185 days
Submission Type
Summary