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510(k) K842026

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

K842026 is an FDA 510(k) premarket notification submitted by Higa Manufacturing , Ltd. for the device "H-TYPE BRIDGE REMOVER". The FDA issued a decision of Substantially Equivalent on July 11, 1984. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565.

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

Other clearances for product code EIS

  • K992649 — ATD AUTOMATIC BRIDGE REMOVER (October 29, 1999)
  • K951299 — EASY PNEUMATIC CROWN AND BRIDGE REMOVER (August 29, 1995)
  • K863500 — STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (September 22, 1986)
  • K854795 — HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (March 4, 1986)
  • K833287 — SATIN CAST ECONOCAST (January 3, 1984)
  • K833290 — C & B 40 PENTRO C & B40 (January 3, 1984)
  • K833289 — C & B 61 PENTRON C & B61 (December 29, 1983)
  • K833278 — C & B 45 (December 29, 1983)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)
  • K833280 — SUPRA AP CHOICE 83 (December 26, 1983)

FDA data resources