The following data is part of a premarket notification filed by Cross Country Paper Products Corp. with the FDA for Cotton Filled Gauze Sponges 2 X 2.
| Device ID | K861727 |
| 510k Number | K861727 |
| Device Name: | COTTON FILLED GAUZE SPONGES 2 X 2 |
| Classification | Cotton, Roll |
| Applicant | CROSS COUNTRY PAPER PRODUCTS CORP. P.O. BOX 558 67 NEWMANS COURT Hempstead, NY 11550 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz CROSS COUNTRY PAPER PRODUCTS CORP. P.O. BOX 558 67 NEWMANS COURT Hempstead, NY 11550 |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-07-10 |