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510(k) K950086

PEDIA PALS, INCORPORATED by Pedia Pals, Inc. — Product Code EPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
January 10, 1995
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 Pedia Pals, Inc.

  • K951040 — BLOOD PRESSURE CUFF 2 (October 31, 1995)
  • K951039 — BLOOD PRESSURE CUFF 1 (October 31, 1995)
  • K951041 — BLOOD PRESSURE CUFF 3 (October 31, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K911650 — PEDIA PALS (October 17, 1991)

Other clearances for product code EPY

  • 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)
  • K780723 — OTOSCOPE SPECULA (May 9, 1978)
  • K772370 — BARRAQUER OVAL SPECULUM-VARIOUS SIZES (January 17, 1978)
  • K772380 — FARRIOR OVAL SPECULUM (January 17, 1978)