SURESKIN STANDARD
FDA 510(k) clearance K960394 · decided 1996-03-01
Clearance details
- K-number
- K960394
- Device name
- SURESKIN STANDARD
- Applicant
- Euromed A/S
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1996-01-29
- Decision date
- 1996-03-01
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Euromed A/S
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
No recalls on record reference this clearance.