POLAR PAD (STERILE)— 510(k) K920581

Substantially Equivalent

Breg, Inc.

FDA 510(k) clearance K920581 for POLAR PAD (STERILE), Substantially Equivalent on 1992-03-20. Applicant: Breg, Inc.. Device class: 2.

Clearance details

Applicant: Breg, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1992-02-10
Decision date: 1992-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K920581

K-number listed on FDA's recall record

Z-0804-2013 — BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.Class II·Terminated·Breg Inc·20130114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920581.

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