The following data is part of a premarket notification filed by Thermedics, Inc. with the FDA for Wound Dressing Model Zb-6.
Device ID | K850076 |
510k Number | K850076 |
Device Name: | WOUND DRESSING MODEL ZB-6 |
Classification | Dressing, Wound, Drug |
Applicant | THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
Contact | Murfitt |
Correspondent | Murfitt THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-09 |
Decision Date | 1985-04-15 |