The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Spin Down Rapidflap.
Device ID | K031034 |
510k Number | K031034 |
Device Name: | SPIN DOWN RAPIDFLAP |
Classification | Plate, Cranioplasty, Preformed, Non-alterable |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Kim Reed |
Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | GXN |
CFR Regulation Number | 882.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-01 |
Decision Date | 2003-05-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841036142049 | K031034 | 000 |
00841036142032 | K031034 | 000 |
00841036142025 | K031034 | 000 |
00841036068028 | K031034 | 000 |
00841036065492 | K031034 | 000 |
00841036058586 | K031034 | 000 |
00888233011273 | K031034 | 000 |
00888233011259 | K031034 | 000 |
00888233011235 | K031034 | 000 |