NON-POWERED COMMUNICATION SYSTEMS
FDA 510(k) clearance K810452 · decided 1981-03-04
Clearance details
- K-number
- K810452
- Device name
- NON-POWERED COMMUNICATION SYSTEMS
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-19
- Decision date
- 1981-03-04
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- ILP
- Device class
- 1
- Regulation number
- 890.3700
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, 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 |
|---|---|---|
| TELL ME TAGS - NONPOWERED COMMUNICATION SYS (K844890) | Mina Manufacturers, Inc. | 1985-03-08 |
| SPEECH TEACHER (K840112) | Joseph A. Resnick | 1984-03-22 |
| ADAPTIVE PENS & LAP DESK (K831546) | Fred Sammons, Inc. | 1983-06-08 |
| MOUTH STICK KIT (K823625) | Fred Sammons, Inc. | 1982-12-30 |
| PICTURES & WORD IDENTIFICATION CVA PAT (K823608) | Fred Sammons, Inc. | 1982-12-30 |
| HOLDER FOR MOUTH STICK (K823624) | Fred Sammons, Inc. | 1982-12-30 |
| ADJ. WOODEN BOARD FOR WRITING (K823612) | Fred Sammons, Inc. | 1982-12-30 |
| KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (K823609) | Fred Sammons, Inc. | 1982-12-22 |
| PLASTIC SLIP-ON PEN/PENCIL HOLDER (K823616) | Fred Sammons, Inc. | 1982-12-22 |
| FLEXIBLE HOLDER TO HOLD PHONE RECEIVER (K823614) | Fred Sammons, Inc. | 1982-12-22 |
| BK-4015 ECONOMY COMMUNICATION SHEET (K823610) | Fred Sammons, Inc. | 1982-12-22 |
| PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (K823617) | Fred Sammons, Inc. | 1982-12-22 |
Recalls involving this device
No recalls on record reference this clearance.