The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Target Program & Epson Hx-20 Computer.
Device ID | K872877 |
510k Number | K872877 |
Device Name: | TARGET PROGRAM & EPSON HX-20 COMPUTER |
Classification | Neurological Stereotaxic Instrument |
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 | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-21 |
Decision Date | 1988-02-12 |