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FDA 510(k), K894828, HPI ORTHO SURGEONS' GLOVE
FDA 510(k), K894828, HPI ORTHO SURGEONS' GLOVE
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510(K) Number: K894828
Device Name: HPI ORTHO SURGEONS' GLOVE
Manufacturer: IMOGENE TIBBETTS
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 07/31/1989
Decision Date: 05/07/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: HPI ORTHO SURGEONS' GLOVE
Manufacturer: IMOGENE TIBBETTS
Device Classification Name: Surgeon'S Gloves
Regulation Number: KGO
Classification Product Code: KXA
Date Received: 07/31/1989
Decision Date: 05/07/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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