FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUN-LITE BLUE SLIT
K Number: K840492
·
Decision May 9, 1984
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
4
Applicant Total
31
Review Days
93
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Basic Information
- Device Name
- SUN-LITE BLUE SLIT
- K Number
- K840492
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Date Received
- February 6, 1984
- Decision Date
- May 9, 1984
- Product Code
- HTP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HTP | File | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTP), ordered by most recent decision date.
INTERMEDICS ORTHOPEDICS REAMERS
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SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
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CONCEPT ARTHROSCOPY RASP
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4MM & 5MM FILE
FDA 510(k)
FDA Class 1
·Orthopedic
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 |