510(k) K771364
- Device
- LUBE JEL
- Applicant
- Travenol Laboratories, S.A.
- 510(k) number
- K771364
- Product code
- FHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-02
- Date received
- 1977-07-25
- Regulation
- 876.1500
- Classification name
- Jelly, Lubricating, For Transurethral Surgical Instrument
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1417592
- 1319660
- 3016761372
- 3011508621
- 3013557562
- 1054241
- 1526711
- 3008751375
- 1060680
- 1055236
- 2320762
- 1043214
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081990 | LUBRICANO STERILE GEL | Farco Pharma GmbH | 2008-12-05 |
| K951713 | BUTTON LUBRICATOR | Fibertech Instruments, Inc. | 1995-04-25 |
| K935548 | CATHEJELL S STERILE LUBRICATING JELLY | Pharmazeutische Fabrik Montavit GmbH | 1994-03-30 |
| K912132 | OPERAND LUBRICATING JELLY | General Medical Co. | 1991-08-07 |
| K780386 | K-Y LUBRICATING JELLY | Johnson & Johnson Professionals, Inc. | 1978-04-13 |