FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPPORT V.T.D.
K Number: K982275
·
Decision Dec 4, 1998
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
10
Review Days
158
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Basic Information
- Device Name
- RAPPORT V.T.D.
- K Number
- K982275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owen Mumford USA, Inc.
- Date Received
- June 29, 1998
- Decision Date
- December 4, 1998
- Product Code
- LKY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Owen Mumford USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013362 | AUTOJECT 2 | Nov 13, 2001 | Substantially Equivalent |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | Nov 10, 1999 | Substantially Equivalent |
| K983994 | UNIFINE | Jan 8, 1999 | Substantially Equivalent |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | Dec 21, 1998 | Substantially Equivalent |
| K983045 | AMIELLE | Nov 25, 1998 | Substantially Equivalent |
| K973899 | UNIFINE PENTIPS | Dec 4, 1997 | Substantially Equivalent |
| K971443 | RAPPORT V.T.D. | Sep 26, 1997 | Substantially Equivalent |
| K953735 | AUTOJECT MINI | Nov 8, 1995 | Substantially Equivalent |
| K945660 | AUTOJECT 2 | Aug 11, 1995 | Substantially Equivalent |