FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONDOM SEAL
K Number: K903715
·
Decision Jan 23, 1991
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
21
Applicant Total
1
Review Days
162
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Basic Information
- Device Name
- CONDOM SEAL
- K Number
- K903715
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mark Sullivan, M.D., P.C.
- Date Received
- August 14, 1990
- Decision Date
- January 23, 1991
- Product Code
- EXJ
- 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 |
|---|---|---|---|
| EXJ | Device, Incontinence, Urosheath Type, Sterile | FDA class 1 | Gastroenterology, Urology |
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