SHEAR, PLASTIC HANDLE UTILITY S-475-7
FDA 510(k) clearance K770481 · decided 1977-04-29
Clearance details
- K-number
- K770481
- Device name
- SHEAR, PLASTIC HANDLE UTILITY S-475-7
- Applicant
- Acme United Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-11
- Decision date
- 1977-04-29
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JOK
- Device class
- 1
- Regulation number
- 880.6820
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Acme United Corp.
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.
| Record | Firm | Date |
|---|---|---|
| SUTURE REMOVAL KIT (K855131) | Dynarex Corp. | 1986-01-13 |
| UTILITY SCISSORS DISPOSABLE ITEMS (K843075) | Greene International Corp. | 1984-09-05 |
| DISPOSABLE SUTURE REMOVAL SCISSORS (K812555) | Medcare Products | 1981-11-16 |
| SUTURE REMOVAL SET (K770595) | Abco Dealers, Inc. | 1977-05-23 |
| SUTURE CUTTER (K770163) | Concept, Inc. | 1977-03-30 |
| DRESSING CHANGE KIT (K761192) | Superior Plastic Products Corp. | 1977-02-28 |
Recalls involving this device
No recalls on record reference this clearance.