FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDSPEC RAYON BALLS
K Number: K800277
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
391
Registration Numbers
392
Same Product Code
18
Applicant Total
15
Review Days
36
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Basic Information
- Device Name
- MEDSPEC RAYON BALLS
- K Number
- K800277
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5300
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medspec Corp.
- Date Received
- February 5, 1980
- Decision Date
- March 12, 1980
- Product Code
- FRL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Medspec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K813012 | STERILE BASIN SETS | Nov 6, 1981 | Substantially Equivalent |
| K812711 | STERILE GAUZE PADS 12PLY | Nov 2, 1981 | Substantially Equivalent |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812709 | STERILE DENTAL ROLL | Oct 23, 1981 | Substantially Equivalent |
| K810071 | STERILE SILICONE TUBING | Feb 12, 1981 | Substantially Equivalent |
| K810069 | STERILE AIRWAY | Feb 2, 1981 | Substantially Equivalent |
| K802060 | STERILE TONSIL SPONGES | Oct 10, 1980 | Substantially Equivalent |
| K801069 | STERILE ISOLATION GOWN | May 20, 1980 | Substantially Equivalent |
| K801068 | STERILE ABDOMINAL PAD | May 20, 1980 | Substantially Equivalent |