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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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