FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRIP, HOSPITAL UTILITY
K Number: K781800
·
Decision Dec 7, 1978
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
2
Review Days
45
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Basic Information
- Device Name
- GRIP, HOSPITAL UTILITY
- K Number
- K781800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Baka Manufacturing Co., Inc.
- Date Received
- October 23, 1978
- Decision Date
- December 7, 1978
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
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Other Clearances by Baka Manufacturing Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Feb 21, 1978 | Substantially Equivalent |