510(k) K904418
- Device
- Ultrasound Coupling Gel
- Applicant
- GENO LABORATORIES
- 510(k) number
- K904418
- Product code
- JOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-11
- Date received
- 1990-09-27
- Regulation
- 878.4400
- Classification name
- Electrode, Gel, Electrosurgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY W GENO
- Address
- 9989 Burbank Dr., Suite 11 Baton Rouge LA US 70810 70810
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923647 | RFG-DGP DISPOSABLE GROUNDING PADS | Radionics, Inc. | 1992-11-09 |
| K905545 | ULTRASOUND TRANSMISSION GEL | Arbo Medical, Inc. | 1991-03-29 |
| K901217 | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL | H & P Industries, Inc. | 1990-06-22 |
| K894490 | STERILE ULTRASOUND TRANSMISSION GEL | Swedish Trade Council USA | 1989-10-05 |
| K884503 | ULTRASONIC TRANSMISSION GEL | Herbert Stanley Co. | 1989-02-13 |
| K872519 | STERILIZED OMNI GEL | Echo Ultrasound | 1987-08-03 |
| K871565 | ULTRASOUND TRANSDUCER GEL, STERILE | Amedic USA | 1987-07-15 |
| K800933 | R2 ELECTROSURG. RETURN ELECT. #225ETC. | R2 Corp. | 1980-05-20 |