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FDA 510(k), K903987, TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
FDA 510(k), K903987, TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
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510(K) Number: K903987
Device Name: TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
Manufacturer: STEPHEN A CAMPBELL
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 08/23/1990
Decision Date: 10/11/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
Manufacturer: STEPHEN A CAMPBELL
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 08/23/1990
Decision Date: 10/11/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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