The following data is part of a premarket notification filed by Medi-tech Intl. Corp. with the FDA for Protective Restraint.
| Device ID | K110377 |
| 510k Number | K110377 |
| Device Name: | PROTECTIVE RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | MEDI-TECH INTL. CORP. 26 COURT ST., SUITE 1301 Brooklyn, NY 11242 |
| Contact | Marilyn Geiger |
| Correspondent | Marilyn Geiger MEDI-TECH INTL. CORP. 26 COURT ST., SUITE 1301 Brooklyn, NY 11242 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-09 |
| Decision Date | 2011-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00027479280139 | K110377 | 000 |
| 10885632133282 | K110377 | 000 |
| 10885632136665 | K110377 | 000 |
| 00027479280009 | K110377 | 000 |
| 00027479280016 | K110377 | 000 |
| 00027479280023 | K110377 | 000 |
| 00027479280030 | K110377 | 000 |
| 00027479280047 | K110377 | 000 |
| 00027479280054 | K110377 | 000 |
| 00027479280115 | K110377 | 000 |
| 00027479280122 | K110377 | 000 |
| 10885632133275 | K110377 | 000 |