SPECULUM, ENT (S3)— 510(k) K951050

Substantially Equivalent

Pedia Pals, Inc.

FDA 510(k) clearance K951050 for SPECULUM, ENT (S3), Substantially Equivalent on 1995-04-17. Applicant: Pedia Pals, Inc.. Device class: 1.

Clearance details

Applicant: Pedia Pals, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-06
Decision date: 1995-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

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More clearances from Pedia Pals, Inc.

K951039 — BLOOD PRESSURE CUFF 11995-10-31
K951040 — BLOOD PRESSURE CUFF 21995-10-31
K951041 — BLOOD PRESSURE CUFF 31995-10-31
K951049 — SPECULUM, ENT (S3)1995-04-17
K950086 — PEDIA PALS, INCORPORATED1995-02-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.