FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNACYT BIOPSY ASPIRATION DEVICE
K Number: K922919
·
Decision Mar 31, 1993
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
6
Applicant Total
111
Review Days
287
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Basic Information
- Device Name
- DYNACYT BIOPSY ASPIRATION DEVICE
- K Number
- K922919
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Buckman Co., Inc.
- Date Received
- June 17, 1992
- Decision Date
- March 31, 1993
- Product Code
- MJG
- 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 |
|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |