FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECNOL COMPRESSION KNEE DRESSING
K Number: K873368
·
Decision Dec 11, 1987
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
35
Review Days
112
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Basic Information
- Device Name
- TECNOL COMPRESSION KNEE DRESSING
- K Number
- K873368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tecnol New Jersey Wound Care, Inc.
- Date Received
- August 21, 1987
- Decision Date
- December 11, 1987
- Product Code
- LLK
- 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 |
|---|---|---|---|
| LLK | Legging, Compression, Non-Inflatable | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLK), ordered by most recent decision date.
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COMPRESSION LEGGING DEVICE
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MODEL 1888 ALPHA COS/RESPIRATION CAR
FDA 510(k)
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Other Clearances by Tecnol New Jersey Wound Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | Aug 23, 1991 | Substantially Equivalent |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | Jul 12, 1991 | Substantially Equivalent |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | Jul 8, 1991 | Substantially Equivalent |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | Feb 27, 1990 | Substantially Equivalent |
| K894205 | TECNOL SILK STRIP | Jul 25, 1989 | Substantially Equivalent |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Jun 23, 1989 | Substantially Equivalent |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | May 30, 1989 | Substantially Equivalent |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | May 23, 1989 | Substantially Equivalent |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Jan 17, 1989 | Substantially Equivalent for Some Indications |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Jul 27, 1988 | Substantially Equivalent |