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510(k) K950086

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

K950086 is an FDA 510(k) premarket notification submitted by Pedia Pals, Inc. for the device "PEDIA PALS, INCORPORATED". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code EPY (Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Pedia Pals, Inc. has at least 6 other 510(k) clearances on record.

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)
  • K951041 — BLOOD PRESSURE CUFF 3 (October 31, 1995)
  • K951039 — BLOOD PRESSURE CUFF 1 (October 31, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — 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)
  • K822370 — UNIVERSAL SPECULUM HOLDER (September 9, 1982)
  • K822373 — EAR SURGERY SPECULUM (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)
  • K772385 — THIN-BLADED NASAL SPECULUM (January 17, 1978)

FDA data resources