The following data is part of a premarket notification filed by Scott Health Care with the FDA for Mesalt Sterile Dressing.
Device ID | K897142 |
510k Number | K897142 |
Device Name: | MESALT STERILE DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
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 | 1989-12-27 |
Decision Date | 1990-03-27 |