FIBER OPTIC HEADLIGHT #60-0765
FDA 510(k) clearance K802769 · decided 1980-12-11
Clearance details
- K-number
- K802769
- Device name
- FIBER OPTIC HEADLIGHT #60-0765
- Applicant
- Aspen Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-03
- Decision date
- 1980-12-11
- Days to decision
- 38 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
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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 ADJUSTABLE HEADLIGHT (K780433) | Cameron-Miller, Inc. | 1978-06-13 |
Recalls involving this device
No recalls on record reference this clearance.