DALE GASTROSTOMY TUBE HOLDER
FDA 510(k) clearance K961693 · decided 1996-07-30
Clearance details
- K-number
- K961693
- Device name
- DALE GASTROSTOMY TUBE HOLDER
- Applicant
- Dale Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-01
- Decision date
- 1996-07-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PLI
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plainville, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dale Medical Products
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.
Recalls involving this device
No recalls on record reference this clearance.