FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZEPPELIN INSTRUMENTS
K Number: K902850
·
Decision Jul 18, 1990
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
5
Review Days
19
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Basic Information
- Device Name
- ZEPPELIN INSTRUMENTS
- K Number
- K902850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Ruggles Corp.
- Date Received
- June 29, 1990
- Decision Date
- July 18, 1990
- Product Code
- HAO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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Other Clearances by Ruggles Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K903485 | TITANIUM MESH | Feb 21, 1991 | Substantially Equivalent |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Sep 20, 1990 | Substantially Equivalent |
| K902819 | LAMINECTOMY ROGEUR | Aug 9, 1990 | Substantially Equivalent |
| K893415 | TRANS-ORAL DEPTH GAUGE | Jun 7, 1989 | Substantially Equivalent |