FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTACLE FRAME - LORRAINE
K Number: K871689
·
Decision May 29, 1987
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
24
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
- SPECTACLE FRAME - LORRAINE
- K Number
- K871689
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- April 29, 1987
- Decision Date
- May 29, 1987
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQZ), ordered by most recent decision date.
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME OR EYEGLASS FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
OPTICAL FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Roseburg SA
| K Number | Device Name | ||
|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | Sep 1, 1994 | Substantially Equivalent |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | Mar 9, 1989 | Substantially Equivalent |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | Jan 24, 1989 | Substantially Equivalent |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | Nov 17, 1987 | Substantially Equivalent |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |
| K864436 | STAVIP 3000 | Mar 16, 1987 | Substantially Equivalent |