510(k) K884503
- Device
- ULTRASONIC TRANSMISSION GEL
- Applicant
- HERBERT STANLEY CO.
- 510(k) number
- K884503
- Product code
- JOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-13
- Date received
- 1988-10-25
- 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
- B DEMASI
- Address
- 8140 N. Ridgeway Skokie IL US 60076 60076
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 |
| K904418 | ULTRASOUND COUPLING GEL | Geno Laboratories | 1991-02-11 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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