FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACH-COLLAR
K Number: K782002
·
Decision Dec 15, 1978
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
21
Applicant Total
48
Review Days
11
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Basic Information
- Device Name
- TRACH-COLLAR
- K Number
- K782002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Concepts, Inc.
- Date Received
- December 4, 1978
- Decision Date
- December 15, 1978
- Product Code
- EQN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Kinetic Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | May 26, 2005 | Substantially Equivalent |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | Jan 25, 2005 | Substantially Equivalent |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | Oct 10, 2003 | Substantially Equivalent |
| K022011 | V.A.C. ABDOMINAL DRESSING | Feb 26, 2003 | Substantially Equivalent |
| K021500 | VACUUM ASSISTED CLOSURE | Dec 20, 2002 | Substantially Equivalent |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | Dec 2, 2002 | Substantially Equivalent |
| K020781 | WET CHAMBER | May 6, 2002 | Substantially Equivalent |
| K992448 | V.A.C. PLUS | Jan 18, 2000 | Substantially Equivalent |
| K972176 | HOME CARE BEAD BED | Jan 16, 1998 | Substantially Equivalent |
| K972549 | SIMPULSE | Nov 18, 1997 | Substantially Equivalent |