510(k) K844890
- Device
- Tell Me Tags - Nonpowered Communication Sys
- Applicant
- MINA MANUFACTURERS, INC.
- 510(k) number
- K844890
- Product code
- ILP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-08
- Date received
- 1984-12-17
- Regulation
- 890.3700
- Classification name
- System, Communication, Non-Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN A MASLOW
- Address
- Fox, Rothschild, O'Brian & Fra 2000 Market St. 10th. Floor Philadelphia PA US 19103 19103
FDA Registration Numbers#
- 1095802
- 2026803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840112 | SPEECH TEACHER | Joseph A. Resnick | 1984-03-22 |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | 1983-06-08 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | 1982-12-30 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | 1982-12-30 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | 1982-12-30 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | 1982-12-30 |
| K823609 | KIT OF WORDS & LTRS TO RE-LEARN-BK4014 | Fred Sammons, Inc. | 1982-12-22 |
| K823610 | BK-4015 ECONOMY COMMUNICATION SHEET | Fred Sammons, Inc. | 1982-12-22 |
| K823613 | PLASTIC STOP TO HOLD TELEPHONE BUTTON | Fred Sammons, Inc. | 1982-12-22 |
| K823614 | FLEXIBLE HOLDER TO HOLD PHONE RECEIVER | Fred Sammons, Inc. | 1982-12-22 |
| K823615 | TELEPHONE ADAPTOR-PERSONS CANT ANSWER | Fred Sammons, Inc. | 1982-12-22 |
| K823616 | PLASTIC SLIP-ON PEN/PENCIL HOLDER | Fred Sammons, Inc. | 1982-12-22 |
| K823617 | PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR | Fred Sammons, Inc. | 1982-12-22 |
| K821644 | VACUUM WAND AND UNI-READER | Fred Sammons, Inc. | 1982-06-11 |
| K811483 | STIM STAND | Fred Sammons, Inc. | 1981-06-16 |