PENLIGHTS— 510(k) K781228

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K781228 for PENLIGHTS, Substantially Equivalent on 1978-09-07. Applicant: Abco Dealers, Inc.. Device class: 1.

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code KYT
Device class: Class 1
Regulation: 21 CFR 880.6350
Advisory panel: General Hospital
Date received: 1978-07-17
Decision date: 1978-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYT

K920782 — OLYMPIC TRANS-LITE1992-03-27
K841588 — SUN-LITE WHITE SPOT1984-05-22
K841589 — C-LITE1984-05-22
K791001 — PENLIGHT/SWAB HOLDER1979-06-22
K760972 — TYCOS DIAGNOSTIC PENLIGHT1977-01-26

More clearances from Abco Dealers, Inc.

K905025 — DIGITAL THERMOMETER KITS1991-02-07
K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)1988-07-12
K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS1988-04-21
K880894 — ALLERGIST SYRINGES1988-03-31
K872875 — STRETCH GAUZE BANDAGES1987-09-04

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