FIBER OPTIC ADJUSTABLE HEADLIGHT
FDA 510(k) clearance K780433 · decided 1978-06-13
Clearance details
- K-number
- K780433
- Device name
- FIBER OPTIC ADJUSTABLE HEADLIGHT
- Applicant
- Cameron-Miller, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-17
- Decision date
- 1978-06-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FCT
- Device class
- 2
- Regulation number
- 886.4335
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cameron-Miller
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIGHT COMMANDER (K960767) | Scieran Technologies, Inc. | 1996-08-26 |
| MODIFIED SITE FIBER OPTIC MODULE (K924198) | Chiron Vision Corp. | 1992-11-23 |
| MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (K883480) | Site Microsurgical Systems, Inc. | 1988-08-24 |
| FIBER OPTIC HEADLIGHT #60-0766766 (K802770) | Aspen Laboratories, Inc. | 1980-12-11 |
| FIBER OPTIC HEADLIGHT #60-0765 (K802769) | Aspen Laboratories, Inc. | 1980-12-11 |
Recalls involving this device
No recalls on record reference this clearance.