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510(k) K830187

FOCUS FLUID by Hematology Marketing Assoc. — Product Code EIF

K830187 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "FOCUS FLUID". The FDA issued a decision of Substantially Equivalent on March 1, 1983. The device falls under product code EIF (Accessories, Retractor, Dental), a Class I device regulated under 21 CFR 872.4565. Hematology Marketing Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1983
Date Received
January 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Retractor, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Hematology Marketing Assoc.

  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851375 — TRI-COUNT (July 12, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850094 — LASER-GLOBIN POWDER (March 29, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K843485 — TRI-COUNT LASER (December 12, 1984)
  • K834371 — TRI-COUNT 10 (March 9, 1984)
  • K833130 — TRI-COUNT 7 (October 20, 1983)

Other clearances for product code EIF

  • K940785 — MOUTH PROPS (October 5, 1994)
  • K873960 — LEWIS SAFE SLEEVE (December 4, 1987)
  • K830116 — SULCARINGS (February 18, 1983)

FDA data resources