FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACIFIC SURGICAL PATTIES
K Number: K993019
·
Decision Mar 30, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
8
Review Days
204
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Basic Information
- Device Name
- PACIFIC SURGICAL PATTIES
- K Number
- K993019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- V. Mueller Neuro/Spine
- Date Received
- September 8, 1999
- Decision Date
- March 30, 2000
- Product Code
- HBA
- 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 |
|---|---|---|---|
| HBA | Neurosurgical Paddie | FDA class 2 | Neurology |
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Other Clearances by V. Mueller Neuro/Spine
| K Number | Device Name | ||
|---|---|---|---|
| K002276 | PSI SKULL CLAMP | Aug 29, 2000 | Substantially Equivalent |
| K991959 | PSI TITANIUM ANEURYSM CLIP | Jan 6, 2000 | Substantially Equivalent |
| K991002 | PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP | Jun 11, 1999 | Substantially Equivalent |
| K972750 | TAKA ANEURYSM CLIP | Jul 9, 1998 | Substantially Equivalent |
| K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | Jan 23, 1997 | Substantially Equivalent |
| K942601 | PSI FLEXIBLE ARM | Dec 27, 1994 | Substantially Equivalent |
| K943635 | ULTRA-LINE RONGEUR | Dec 7, 1994 | Substantially Equivalent |