The following data is part of a premarket notification filed by Synergistic Medical Technologies, Inc. with the FDA for Endo-judge.
Device ID | K932591 |
510k Number | K932591 |
Device Name: | ENDO-JUDGE |
Classification | Needle, Suturing, Disposable |
Applicant | SYNERGISTIC MEDICAL TECHNOLOGIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan SYNERGISTIC MEDICAL TECHNOLOGIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Product Code | GAB |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-28 |
Decision Date | 1993-12-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDO-JUDGE 74663107 1960338 Live/Registered |
SYNERGISTIC MEDICAL TECHNOLOGIES, INCORPORATED 1995-04-18 |
ENDO-JUDGE 74502337 not registered Dead/Abandoned |
SYNERGISTIC MEDICAL TECHNOLOGIES, INCORPORATED 1994-03-21 |