FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACHEOSTOMY CARE TRAYS
K Number: K821269
·
Decision May 27, 1982
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
16
Review Days
24
Basic Information
- Device Name
- TRACHEOSTOMY CARE TRAYS
- K Number
- K821269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- INTERMED, INC.
- Date Received
- May 3, 1982
- Decision Date
- May 27, 1982
- 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 INTERMED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | May 22, 1990 | Unknown |
| K842166 | INTERMED, INS STERILE WATER/SALINE | Feb 12, 1985 | Substantially Equivalent |
| K833126 | DRESSING CHANGE TRAYS | Jan 27, 1984 | Substantially Equivalent |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | Jan 11, 1984 | Substantially Equivalent |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | Jan 11, 1984 | Substantially Equivalent |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent |
| K833059 | SUCTION CATHETER TRAYS | Dec 12, 1983 | Substantially Equivalent |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Sep 7, 1979 | Substantially Equivalent |
| K791426 | PERITONEAL PAC | Aug 28, 1979 | Substantially Equivalent |
| K781748 | IRRIGATION TRAY | Dec 12, 1978 | Substantially Equivalent |