SHIRT, MITTEN CUFF INFANT
FDA 510(k) clearance K760360 · decided 1976-10-20
Clearance details
- K-number
- K760360
- Device name
- SHIRT, MITTEN CUFF INFANT
- Applicant
- Precept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-08-02
- Decision date
- 1976-10-20
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FME
- Device class
- 1
- Regulation number
- 880.6265
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KIMBERLY-CLARK PROFESSIONAL JACKET (K880385) | Kimberly-Clark Corp. | 1988-02-19 |
| MONITOR/VITAL SIGNS TRAY (K811915) | American Hospital Supply Corp. | 1981-07-28 |
| EXAM GOWN (K770476) | General Medical Co. | 1977-05-06 |
| CROWNTEX EXAM. CAPE & GOWN (K760954) | Graham Manufacturing Co. | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.