FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMALAP
K Number: K893212
·
Decision Jun 1, 1989
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
34
Review Days
35
Basic Information
- Device Name
- THERMALAP
- K Number
- K893212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- O.R. CONCEPTS, INC.
- Date Received
- April 27, 1989
- Decision Date
- June 1, 1989
- 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 | FDA class 2 | General, Plastic Surgery |
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Other Clearances by O.R. CONCEPTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | Aug 17, 1994 | Substantially Equivalent |
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| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | Mar 7, 1994 | Substantially Equivalent |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | Oct 15, 1993 | Substantially Equivalent |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | Sep 24, 1993 | Substantially Equivalent |
| K922197 | INSUFFLATOR TUBING KIT | Sep 24, 1993 | Substantially Equivalent |
| K932449 | DR. FOG | Aug 11, 1993 | Substantially Equivalent |
| K925147 | ORC 10.0MM SUCTION PROBE | Jun 25, 1993 | Substantially Equivalent |
| K925024 | ORC TAPPERED IRRIGATING PROBE | May 21, 1993 | Substantially Equivalent |