The following data is part of a premarket notification filed by Consolidated Products & Services, Inc. with the FDA for Cp & S Sterile Burn Sheet.
Device ID | K930759 |
510k Number | K930759 |
Device Name: | CP & S STERILE BURN SHEET |
Classification | Sheet, Burn |
Applicant | CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
Contact | Ellen J O'donnell |
Correspondent | Ellen J O'donnell CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
Product Code | FPY |
CFR Regulation Number | 880.5180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-12 |
Decision Date | 1994-01-21 |