510(k) K935548
- Device
- CATHEJELL S STERILE LUBRICATING JELLY
- Applicant
- PHARMAZEUTISCHE FABRIK MONTAVIT GMBH
- 510(k) number
- K935548
- Product code
- FHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-30
- Date received
- 1993-11-17
- 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
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HENRY S PERDUE, PH.D
- Address
- Cmr Associates 372 Danbury Rd. Wilton CT US 06897 06897
FDA Registration Numbers#
- 1526711
- 3013557562
- 1060680
- 1054241
- 1417592
- 1043214
- 1055236
- 2320762
- 3016761372
- 1319660
- 3011508621
- 3008751375
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 |
| K912132 | OPERAND LUBRICATING JELLY | General Medical Co. | 1991-08-07 |
| K780386 | K-Y LUBRICATING JELLY | Johnson & Johnson Professionals, Inc. | 1978-04-13 |
| K771364 | LUBE JEL | Travenol Laboratories, S.A. | 1977-08-02 |
Legacy Summary#
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FDA Review#
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