Iris Retractor
FDA 510(k) K770222 · Concept, Inc.
510(k) numberK770222
Submission
- Device name
- Iris Retractor
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- February 3, 1977
- Decision date
- February 17, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNI – Retractor, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
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|---|---|---|---|
| K991592 | Ksea de la Plaza Blepharoplasty SetHNI · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/02/1999SE |
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Questions and answers
When was Iris Retractor cleared by the FDA?
Iris Retractor (K770222) received a 510(k) decision of Substantially Equivalent on February 17, 1977, 14 days after the submission was received.
What is the product code of K770222?
The FDA product code is HNI – Retractor, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.