RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE— 510(k) K931874

Name: FDA 510(k) clearance K931874
Creator: U.S. Food and Drug Administration
Published: 1994-06-10

Substantially Equivalent

Amsco Sterile Recoveries, Inc.

FDA 510(k) clearance K931874 for RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE, Substantially Equivalent on 1994-06-10. Applicant: Amsco Sterile Recoveries, Inc.. Device class: 2.

Clearance details

Applicant: Amsco Sterile Recoveries, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1993-04-14
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amsco Sterile Recoveries, Inc.

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K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS1994-09-09
K931143 — AMSCO STERILE RECOVERIES ABSORBENT TOWELS1994-09-08
K931146 — SURGICAL DRAPES, MODIFICATION1994-06-13
K931144 — STERILE SURGEON'S GOWN, MODIFICATION1994-06-10
K931145 — NON-STERILE ISOLATION GOWN1994-06-10

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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