FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUCLEOTOME
K Number: K844131
·
Decision Nov 29, 1984
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
22
Review Days
37
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Basic Information
- Device Name
- NUCLEOTOME
- K Number
- K844131
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Date Received
- October 23, 1984
- Decision Date
- November 29, 1984
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K992943 | VIT ENHANCER | Dec 10, 1999 | Substantially Equivalent |
| K971067 | DIGI-INJECTOR | Sep 19, 1997 | Substantially Equivalent |
| K950287 | UNIVIT PROBE | Apr 10, 1995 | Substantially Equivalent |
| K934600 | MICRODRIVE | Jul 27, 1994 | Substantially Equivalent |
| K932669 | SUPRA-VIT(TM) | Jun 3, 1994 | Substantially Equivalent |
| K932131 | MID LABS TWIN ILLUMINATOR | Apr 1, 1994 | Substantially Equivalent |
| K924222 | MID LABS, INC. VIT MATE | Jan 27, 1993 | Substantially Equivalent |
| K851610 | COMBINED MVS SYSTEMS | Jul 22, 1985 | Substantially Equivalent |