FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C-LITE
K Number: K841589
·
Decision May 22, 1984
Classifications
1
FEI Numbers
156
Registration Numbers
156
Same Product Code
5
Applicant Total
31
Review Days
34
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Basic Information
- Device Name
- C-LITE
- K Number
- K841589
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6350
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Date Received
- April 18, 1984
- Decision Date
- May 22, 1984
- Product Code
- KYT
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYT), ordered by most recent decision date.
OLYMPIC TRANS-LITE
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SUN-LITE WHITE SPOT
FDA 510(k)
FDA Class 1
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PENLIGHT/SWAB HOLDER
FDA 510(k)
FDA Class 1
·General Hospital
PENLIGHTS
FDA 510(k)
FDA Class 1
·General Hospital
TYCOS DIAGNOSTIC PENLIGHT
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Suncoast Medical Manufacturers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | Dec 7, 1984 | Substantially Equivalent |
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | Dec 7, 1984 | Substantially Equivalent |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | Dec 7, 1984 | Substantially Equivalent |
| K841603 | ADJUST-A-TEMP MICRO | Dec 7, 1984 | Substantially Equivalent |
| K841591 | PYRO-TIP | Oct 31, 1984 | Substantially Equivalent |
| K840376 | SURG-A STAT LOOP TIP | Oct 26, 1984 | Substantially Equivalent |
| K840375 | SURG-A-STAT LOOP TIP 15 | Jul 23, 1984 | Substantially Equivalent |
| K840387 | SURG-A-STAT LOOP TIP 2 | Jul 23, 1984 | Substantially Equivalent |
| K840370 | SURG-A-STAT VASECTOMY TIP | Jul 23, 1984 | Substantially Equivalent |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | Jul 23, 1984 | Substantially Equivalent |