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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K941327
FOIA Releasable 510(k) K941327
Device Name CROSSTEX SELF-SEALING STERILIZATION POUCH
Applicant
CROSS COUNTRY PAPER PRODUCTS CORP.
10 RANICK RD.
P.O. BOX 13188
HAUPPAUGE,  NY  11788
Applicant Contact MILTON N BENEKE, JR.
Correspondent
CROSS COUNTRY PAPER PRODUCTS CORP.
10 RANICK RD.
P.O. BOX 13188
HAUPPAUGE,  NY  11788
Correspondent Contact MILTON N BENEKE, JR.
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/18/1994
Decision Date 12/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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