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510(k) K821177

BITE STICK by Abco Dealers, Inc. — Product Code FMA

K821177 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "BITE STICK". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code FMA (Depressor, Tongue, Non-Surgical), a Class I device regulated under 21 CFR 880.6230. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Depressor, Tongue, Non-Surgical
Device Class
Class I
Regulation Number
880.6230
Review Panel
HO
Submission Type

Other clearances by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code FMA

  • K992995 — AROMATIC AND FLAVORED TONGUE DEPRESSOR (December 9, 1999)
  • K842461 — TONGUE DEPRESSOR (November 30, 1984)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K770120 — MOUTH WASH TRAY (January 28, 1977)

FDA data resources