TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
FDA 510(k) clearance K061308 · decided 2006-06-05
Clearance details
- K-number
- K061308
- Device name
- TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
- Applicant
- Cardinal Health 200, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-10
- Decision date
- 2006-06-05
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardinal Health 200
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA recall (Z-1002-2020) | Cardinal Health | 2020-01-24 |
| AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB recall (Z-1004-2020) | Cardinal Health | 2020-01-24 |
| AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA recall (Z-1005-2020) | Cardinal Health | 2020-01-24 |
| AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB recall (Z-1006-2020) | Cardinal Health | 2020-01-24 |
| AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB recall (Z-1008-2020) | Cardinal Health | 2020-01-24 |
| AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA recall (Z-1017-2020) | Cardinal Health | 2020-01-24 |