The following data is part of a premarket notification filed by Prosper, Inc. with the FDA for Skin Stapling Device Sc2000.
Device ID | K832709 |
510k Number | K832709 |
Device Name: | SKIN STAPLING DEVICE SC2000 |
Classification | Staple, Removable (skin) |
Applicant | PROSPER, INC. BOX 42 Richland , MI 49083 - |
Contact | Syncare, Inc. |
Correspondent | Syncare, Inc. PROSPER, INC. BOX 42 Richland , MI 49083 - |
Product Code | GDT |
CFR Regulation Number | 878.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-12 |
Decision Date | 1983-09-26 |