FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
B & B I/A HANDPIECE
K Number: K881517
·
Decision Aug 22, 1988
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
5
Review Days
133
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Basic Information
- Device Name
- B & B I/A HANDPIECE
- K Number
- K881517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- B&B Medical Assoc., Inc.
- Date Received
- April 11, 1988
- Decision Date
- August 22, 1988
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by B&B Medical Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881707 | INTROCULAR FLUID INJECTOR | Oct 21, 1988 | Substantially Equivalent |
| K881519 | VAC-G (GUILLOTINE VITRECTOR) | Sep 8, 1988 | Substantially Equivalent |
| K881520 | VAC (OSCILLATING VITRECTOR) | Sep 7, 1988 | Substantially Equivalent |
| K881518 | INFUSION HANDLE | Aug 22, 1988 | Substantially Equivalent |