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510(k) K832500

CS-11 by Chema-Scutum, Inc. — Product Code EBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
July 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Denture Hydrophilic, Resin
Device Class
Class II
Regulation Number
872.3300
Review Panel
DE
Submission Type

Other clearances for product code EBE

  • K830491 — JOHNSON & JOHNSON OPAQUE COLOR MODIFI (March 17, 1983)
  • K790339 — CONCEPT II (July 17, 1979)