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FDA 510(k), K897192, TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
FDA 510(k), K897192, TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
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510(K) Number: K897192
Device Name: TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
Manufacturer: A CAMPBELL
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 12/28/1989
Decision Date: 02/15/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
Manufacturer: A CAMPBELL
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 12/28/1989
Decision Date: 02/15/1990
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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