PART #860065 IA PAK & PART #860060 IA PAK
FDA 510(k) clearance K871473 · decided 1987-08-10
Clearance details
- K-number
- K871473
- Device name
- PART #860065 IA PAK & PART #860060 IA PAK
- Applicant
- Medical Technical Products
- Decision
- Substantially Equivalent
- Date received
- 1987-04-14
- Decision date
- 1987-08-10
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.