FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BKS-42 DISPOSABLE VACUUM TUBING PACK
K Number: K864065
·
Decision Dec 15, 1986
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
33
Review Days
56
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Basic Information
- Device Name
- BKS-42 DISPOSABLE VACUUM TUBING PACK
- K Number
- K864065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Allergan, Inc.
- Date Received
- October 20, 1986
- Decision Date
- December 15, 1986
- Product Code
- HNO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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