FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
K Number: K860977
·
Decision Oct 16, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
17
Review Days
216
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Basic Information
- Device Name
- MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
- K Number
- K860977
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Britt Corp., Inc.
- Date Received
- March 14, 1986
- Decision Date
- October 16, 1986
- Product Code
- LLF
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LLF | Laser, Neurosurgical, Argon | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLF), ordered by most recent decision date.
ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
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·Unknown
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
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FDA Class 3
·Unknown
COOPER MEDICAL MODEL 770
FDA 510(k)
FDA Class 3
·Unknown
Other Clearances by Britt Corp., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003828 | VASO PRESS DVT FOOT GARMENT #VP 520 | May 18, 2001 | Substantially Equivalent |
| K991038 | VASO PRESS DVT SYSTEM, MODELS VP500, VP501 | Jun 22, 2000 | Substantially Equivalent |
| K974393 | VASO PRESS SYSTEM | Mar 19, 1999 | Substantially Equivalent |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Jul 18, 1986 | Substantially Equivalent |
| K860974 | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL | Jul 7, 1986 | Substantially Equivalent |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | May 6, 1986 | Substantially Equivalent |
| K860273 | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY | Apr 23, 1986 | Substantially Equivalent |
| K860278 | MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC | Apr 15, 1986 | Substantially Equivalent |
| K851425 | MODEL J25-25 WATT CO2 LASER | Nov 12, 1985 | Substantially Equivalent |
| K840020 | FITNESS LOGGER | Oct 26, 1984 | Unknown |