The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Silastic Nasal Implant S-type.
Device ID | K880405 |
510k Number | K880405 |
Device Name: | SILASTIC NASAL IMPLANT S-TYPE |
Classification | Prosthesis, Nose, Internal |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Lipscomb, Phd |
Correspondent | Lipscomb, Phd DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | FZE |
CFR Regulation Number | 878.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-29 |
Decision Date | 1988-02-18 |