ALM ILLUMINATOR SERIES LIGHT SYSTEM
FDA 510(k) clearance K922409 · decided 1993-01-12
Clearance details
- K-number
- K922409
- Device name
- ALM ILLUMINATOR SERIES LIGHT SYSTEM
- Applicant
- Alm Surgical Equipment, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-21
- Decision date
- 1993-01-12
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- FSQ
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT (K932139) | Aaron Medical Industries | 1993-07-30 |
| MIDMARK SURGICAL LIGHTING SYSTEMS (K930686) | Midmark Corp. | 1993-07-30 |
| BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (K921848) | Alm Surgical Equipment, Inc. | 1992-10-01 |
| SURG-FLEX 10 LIGHT (K803067) | Medical Products Development, Inc. | 1981-02-26 |
| SURG-FLEX 15 SURGICAL LIGHT (K810019) | Medical Products Development, Inc. | 1981-01-23 |
| SURG-FLEX 5 SURGICAL LIGHT (K810018) | Medical Products Development, Inc. | 1981-01-23 |
Recalls involving this device
No recalls on record reference this clearance.