FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DISPOS. ACU-CUT SOFT TISSUE BIOPSY
K Number: K842091
·
Decision Jul 23, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
29
Review Days
60
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Basic Information
- Device Name
- DISPOS. ACU-CUT SOFT TISSUE BIOPSY
- K Number
- K842091
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- The Healthcare Group Laboratories, Inc.
- Date Received
- May 24, 1984
- Decision Date
- July 23, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| 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 |
| K822059 | SHOW'RBAG | Jul 22, 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 |