FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUFF UNDERPAD TYPE UP1001
K Number: K802740
·
Decision Dec 10, 1980
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
11
Review Days
37
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Basic Information
- Device Name
- FLUFF UNDERPAD TYPE UP1001
- K Number
- K802740
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Bio D Corp.
- Date Received
- November 3, 1980
- Decision Date
- December 10, 1980
- Product Code
- KME
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Bio D Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K802736 | URINE COOLECTION BAG TYPE 2090V | Dec 18, 1980 | Substantially Equivalent |
| K802735 | URINE COLLECTION BAG TYPE 740AP | Dec 18, 1980 | Substantially Equivalent |
| K802734 | URINE COLLECTION BAG TYPE 710 | Dec 18, 1980 | Substantially Equivalent |
| K802733 | URINE COLLECTION BAG TYPE AP2090V | Dec 18, 1980 | Substantially Equivalent |
| K802738 | URINE COLLECTION BAG TYPE 1505V | Dec 18, 1980 | Substantially Equivalent |
| K802729 | URINE COLLECTION BAG TYPE 2132V | Dec 18, 1980 | Substantially Equivalent |
| K802732 | URINE COLLECTION BAG TYPE AP2132V | Dec 18, 1980 | Substantially Equivalent |
| K802737 | URINE COLLECTION BAG TYPE 1590V | Dec 18, 1980 | Substantially Equivalent |
| K802739 | URINE COLLECTION BAG TYPE 710AP | Dec 18, 1980 | Substantially Equivalent |
| K802730 | FLUFF UNDERPAD TYPE UP1002 | Dec 10, 1980 | Substantially Equivalent |