The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Skin Staple Remover Kit.
Device ID | K915430 |
510k Number | K915430 |
Device Name: | SKIN STAPLE REMOVER KIT |
Classification | Staple, Removable (skin) |
Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Contact | Varun Soni |
Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Product Code | GDT |
CFR Regulation Number | 878.4760 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-02 |
Decision Date | 1992-02-28 |