CROSSTEX SELF-SEALING STERILIZATION POUCH— 510(k) K941327

Name: FDA 510(k) clearance K941327
Creator: U.S. Food and Drug Administration
Published: 1994-12-22

Substantially Equivalent

Cross Country Paper Products Corp.

FDA 510(k) clearance K941327 for CROSSTEX SELF-SEALING STERILIZATION POUCH, Substantially Equivalent on 1994-12-22. Applicant: Cross Country Paper Products Corp.. Device class: 2.

Clearance details

Applicant: Cross Country Paper Products Corp.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1994-03-18
Decision date: 1994-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K941327

K-number listed on FDA's recall record

Z-1791-2022 — SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.Class III·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K941327.

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