FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TLS BULB DRAINAGE SYSTEM
K Number: K833586
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
15
Review Days
110
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Basic Information
- Device Name
- TLS BULB DRAINAGE SYSTEM
- K Number
- K833586
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- October 12, 1983
- Decision Date
- January 30, 1984
- Product Code
- GCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Porex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | Oct 20, 1987 | Substantially Equivalent |
| K873044 | POREX OTOLOGY INSTRUMENTS | Sep 4, 1987 | Substantially Equivalent |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Aug 21, 1987 | Substantially Equivalent |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K870154 | POREX(TM) TISSUE EXPANDER | Feb 24, 1987 | Substantially Equivalent |
| K870182 | POREX(TM) MALAR IMPLANT | Feb 24, 1987 | Substantially Equivalent |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | Feb 24, 1987 | Substantially Equivalent |
| K863939 | POREX(TM) EAR PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863942 | POREX(TM) NOSE PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |