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 |