FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOW'RBAG
K Number: K822059
·
Decision Jul 22, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
29
Review Days
9
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Basic Information
- Device Name
- SHOW'RBAG
- K Number
- K822059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- The Healthcare Group Laboratories, Inc.
- Date Received
- July 13, 1982
- Decision Date
- July 22, 1982
- Product Code
- LGF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LGF | Component, Cast | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGF), ordered by most recent decision date.
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Other Clearances by The Healthcare Group Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | Jun 7, 1985 | Substantially Equivalent |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | Oct 19, 1984 | Substantially Equivalent |
| K842091 | DISPOS. ACU-CUT SOFT TISSUE BIOPSY | Jul 23, 1984 | Substantially Equivalent |
| K840742 | RIGHT ATRIAL CATHETER | Jul 13, 1984 | Substantially Equivalent |
| K830299 | SOLUTION TRANSFER CONTAINER | Feb 19, 1983 | Substantially Equivalent |
| K822307 | ADHESIVE SPRAY #4050-4060 | Sep 24, 1982 | Substantially Equivalent |
| K821480 | RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT | Jun 17, 1982 | Substantially Equivalent |
| K821230 | SOFTIC 49 | May 28, 1982 | Substantially Equivalent |
| K821162 | ADHESIVE REMOVER | May 14, 1982 | Substantially Equivalent |
| K821172 | EXTERNAL FEMALE URINARY INCONTINENCE | May 10, 1982 | Substantially Equivalent |