510(k) K872519
- Device
- STERILIZED OMNI GEL
- Applicant
- ECHO ULTRASOUND
- 510(k) number
- K872519
- Product code
- JOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-03
- Date received
- 1987-06-25
- 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
- DAVID SZCZUPAKOWSKI
- Address
- Post Office Box 552 Lewistown PA US 17044 17044
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 |
| K884503 | ULTRASONIC TRANSMISSION GEL | Herbert Stanley Co. | 1989-02-13 |
| 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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