FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASSENAT-BLESCHET SUNGLASSES
K Number: K885275
·
Decision Jan 24, 1989
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
24
Review Days
28
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
- ASSENAT-BLESCHET SUNGLASSES
- K Number
- K885275
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- December 27, 1988
- Decision Date
- January 24, 1989
- Product Code
- HQY
- 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MULTI
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 |
| 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 |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |
| K864436 | STAVIP 3000 | Mar 16, 1987 | Substantially Equivalent |