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510(k) K842026

H-TYPE BRIDGE REMOVER by Higa Manufacturing , Ltd. — Product Code EIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
May 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Crown
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)