The following data is part of a premarket notification filed by Cross Country Paper Products Corp. with the FDA for Surgical Scalpel Blades & Disposables.
Device ID | K844759 |
510k Number | K844759 |
Device Name: | SURGICAL SCALPEL BLADES & DISPOSABLES |
Classification | Blade, Scalpel |
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 | GES |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-07 |
Decision Date | 1985-01-18 |