SAGITTAL SAW— 510(k) K800313

Substantially Equivalent

Black & Decker(Tm)

FDA 510(k) clearance K800313 for SAGITTAL SAW, Substantially Equivalent on 1980-02-22. Applicant: Black & Decker(Tm). Device class: 1.

Clearance details

Applicant: Black & Decker(Tm)
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1980-02-12
Decision date: 1980-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIJ

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K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115)1997-04-30

More clearances from Black & Decker(Tm)

K820351 — CAST CUTTER/CAST SAW/INSTRUMENT1982-03-02
K812436 — 450/800 DRILL1981-11-02
K812437 — 150 DRIVER REAMER1981-11-02
K812438 — SAGITTAL SAW1981-11-02
K812439 — DUAL MPC CHARGER1981-11-02

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