MEDI-SEAL STERILIZATION POUCHES & TUB— 510(k) K821331

Name: FDA 510(k) clearance K821331
Creator: U.S. Food and Drug Administration
Published: 1982-06-07

Substantially Equivalent

Medical Industries Packaging, Inc.

FDA 510(k) clearance K821331 for MEDI-SEAL STERILIZATION POUCHES & TUB, Substantially Equivalent on 1982-06-07. Applicant: Medical Industries Packaging, Inc.. Device class: 2.

Clearance details

Applicant: Medical Industries Packaging, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1982-05-04
Decision date: 1982-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
K251347 — Sterilization Pouch/Roll2026-01-28
K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

More clearances from Medical Industries Packaging, Inc.

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K832128 — SELF-SEAL STERILIZATION POUCHES1983-08-08
K831165 — DUSTCOVERS/STERILITY MAINTENANCE COVERS1983-05-03
K830961 — EASY BREATHER HEADER BAGS1983-04-12
K821330 — GAS STERILIZATION POUCHES1982-06-07
K821332 — DUSTCOVERS &/OR STERILITY MAINT. COVERS1982-05-27

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.