The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Stent.
| Device ID | K896667 |
| 510k Number | K896667 |
| Device Name: | LORENZ STENT |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Debra A Powers |
| Correspondent | Debra A Powers WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036138714 | K896667 | 000 |
| 00841036026066 | K896667 | 000 |
| 00841036026059 | K896667 | 000 |
| 00841036026042 | K896667 | 000 |
| 00841036026035 | K896667 | 000 |
| 00841036026028 | K896667 | 000 |
| 00841036026011 | K896667 | 000 |
| 00841036026004 | K896667 | 000 |
| 00841036025991 | K896667 | 000 |
| 00841036025984 | K896667 | 000 |
| 00841036025977 | K896667 | 000 |
| 00841036025960 | K896667 | 000 |
| 00841036025953 | K896667 | 000 |
| 00841036025946 | K896667 | 000 |
| 00841036025939 | K896667 | 000 |
| 00841036026073 | K896667 | 000 |
| 00841036026080 | K896667 | 000 |
| 00841036138707 | K896667 | 000 |
| 00841036138691 | K896667 | 000 |
| 00841036138684 | K896667 | 000 |
| 00841036138677 | K896667 | 000 |
| 00841036138660 | K896667 | 000 |
| 00841036138653 | K896667 | 000 |
| 00841036138646 | K896667 | 000 |
| 00841036091231 | K896667 | 000 |
| 00841036026141 | K896667 | 000 |
| 00841036026134 | K896667 | 000 |
| 00841036026127 | K896667 | 000 |
| 00841036026110 | K896667 | 000 |
| 00841036026103 | K896667 | 000 |
| 00841036026097 | K896667 | 000 |
| 00841036025922 | K896667 | 000 |