FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROSEBUD DISSECTOR
K Number: K953060
·
Decision Sep 14, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
111
Applicant Total
7
Review Days
76
Basic Information
- Device Name
- ROSEBUD DISSECTOR
- K Number
- K953060
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDICAL PERSPECTIVES CORP.
- Date Received
- June 30, 1995
- Decision Date
- September 14, 1995
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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CPR LAP SPONGES
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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ROUND STICK SPONGES, FLAT STICK SPONGES
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Other Clearances by MEDICAL PERSPECTIVES CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Sep 14, 1995 | Substantially Equivalent |
| K953062 | CHERRY DISSECTOR | Sep 14, 1995 | Substantially Equivalent |
| K953087 | CHERRY PIT DISSECTOR | Sep 14, 1995 | Substantially Equivalent |
| K953088 | TRIANGULAR SPONGES | Sep 14, 1995 | Substantially Equivalent |
| K953059 | KITTNER DISSECTOR | Sep 14, 1995 | Substantially Equivalent |
| K953057 | CYLINDRICAL SPONGE | Sep 14, 1995 | Substantially Equivalent |