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510(k) K884295

SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE by Saybrex Intl., Inc. — Product Code LGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1988
Date Received
October 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

Other clearances by Saybrex Intl., Inc.

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