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510(k) K780723

OTOSCOPE SPECULA by Abco Dealers, Inc. — Product Code EPY

K780723 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "OTOSCOPE SPECULA". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code EPY (Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1978
Date Received
May 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
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 EPY

  • K950086 — PEDIA PALS, INCORPORATED (February 7, 1995)
  • K925754 — ECONOM (October 8, 1993)
  • K853588 — FIBRELIGHT NASAL SPECULA (December 18, 1985)
  • K834189 — JAKOBI SURG. INSTRUMENTS #7 44/47 (March 6, 1984)
  • K822373 — EAR SURGERY SPECULUM (September 9, 1982)
  • K822370 — UNIVERSAL SPECULUM HOLDER (September 9, 1982)
  • K822164 — EAR SPECULI (August 11, 1982)
  • K791123 — EAR AND NOSE SPECULA (July 10, 1979)
  • K772385 — THIN-BLADED NASAL SPECULUM (January 17, 1978)
  • K772380 — FARRIOR OVAL SPECULUM (January 17, 1978)

FDA data resources