FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECISION - COSMET CAPSULE COUPEUR
K Number: K852934
·
Decision Aug 8, 1985
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
4
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PRECISION - COSMET CAPSULE COUPEUR
- K Number
- K852934
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Precision-Cosmet Co., Inc.
- Date Received
- July 9, 1985
- Decision Date
- August 8, 1985
- Product Code
- HNY
- 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 |
|---|---|---|---|
| HNY | Cystotome | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNY), ordered by most recent decision date.
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
FDA 510(k)
FDA Class 1
·Ophthalmic
CYSTOTOMES/KNIFES
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic