SYRINGE INJECTION GUN DELIVERY KITS
FDA 510(k) clearance K890658 · decided 1989-10-03
Clearance details
- K-number
- K890658
- Device name
- SYRINGE INJECTION GUN DELIVERY KITS
- Applicant
- Gastrotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-08
- Decision date
- 1989-10-03
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Independence, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gastrotech
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.