PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
FDA 510(k) clearance K874976 · decided 1988-04-13
Clearance details
- K-number
- K874976
- Device name
- PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
- Applicant
- Advanced Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-02
- Decision date
- 1988-04-13
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- HNY
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chesterfield, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.