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510(k) K885299

SANI-SLEEVE DRAPE FOR DENTAL USE by Nieusma R & D, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
December 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Nieusma R & D, Inc.

  • K892881 — DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (June 23, 1989)
  • K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (June 23, 1989)

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