IRIS RETRACTOR
FDA 510(k) clearance K770222 · decided 1977-02-17
Clearance details
- K-number
- K770222
- Device name
- IRIS RETRACTOR
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-03
- Decision date
- 1977-02-17
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HNI
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| KSEA DE LA PLAZA BLEPHAROPLASTY SET (K991592) | KARL STORZ Endoscopy-America, Inc. | 1999-11-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |