The following data is part of a premarket notification filed by Watson Phillips Y Cia. Sucs., S.a. De C.v. with the FDA for Yesona Plaster Of Paris Bandage.
Device ID | K831492 |
510k Number | K831492 |
Device Name: | YESONA PLASTER OF PARIS BANDAGE |
Classification | Bandage, Cast |
Applicant | WATSON PHILLIPS Y CIA. SUCS., S.A. DE C.V. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ITG |
CFR Regulation Number | 890.3025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-10 |
Decision Date | 1983-06-30 |