The following data is part of a premarket notification filed by Cross Country Paper Products Corp. with the FDA for Crosstex Self-sealing Sterilization Pouch.
Device ID | K941327 |
510k Number | K941327 |
Device Name: | CROSSTEX SELF-SEALING STERILIZATION POUCH |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | CROSS COUNTRY PAPER PRODUCTS CORP. 10 RANICK RD. P.O. BOX 13188 Hauppauge, NY 11788 |
Contact | Milton N Beneke, Jr. |
Correspondent | Milton N Beneke, Jr. CROSS COUNTRY PAPER PRODUCTS CORP. 10 RANICK RD. P.O. BOX 13188 Hauppauge, NY 11788 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-18 |
Decision Date | 1994-12-22 |