FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORS-111
K Number: K953654
·
Decision Sep 22, 1995
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
7
Review Days
51
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Basic Information
- Device Name
- ORS-111
- K Number
- K953654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- O.R. Solutions, Inc.
- Date Received
- August 2, 1995
- Decision Date
- September 22, 1995
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by O.R. Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051979 | ORS MODEL 6000 ENDOSCOPE HOLDER | Aug 30, 2005 | Substantially Equivalent |
| K023282 | ORS-3000LD | Nov 13, 2002 | Substantially Equivalent |
| K023283 | 1075LD HUSH-SLUSH | Nov 13, 2002 | Substantially Equivalent |
| K021288 | ORS-1000LD | Jun 27, 2002 | Substantially Equivalent |
| K021289 | WARMER 2000LD | Jun 26, 2002 | Substantially Equivalent |
| K960836 | DMS-9000 | Sep 12, 1996 | Substantially Equivalent |