The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Surgimat.
Device ID | K926259 |
510k Number | K926259 |
Device Name: | SURGIMAT |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | W.O.M. WORLD OF MEDICINE, GMBH 8536 CALLE TIOGA Tucson, AR 85704 |
Contact | Owen B Lamb |
Correspondent | Owen B Lamb W.O.M. WORLD OF MEDICINE, GMBH 8536 CALLE TIOGA Tucson, AR 85704 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1994-09-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGIMAT 74218904 1742979 Dead/Cancelled |
TECNOL MEDICAL PRODUCTS, INC. 1991-11-04 |