The following data is part of a premarket notification filed by International Medical Industries, Inc. with the FDA for Tamper Evident Cap For Use With Enfit Syringes.
| Device ID | K170672 |
| 510k Number | K170672 |
| Device Name: | Tamper Evident Cap For Use With ENFit Syringes |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Contact | Brandon Hunt |
| Correspondent | Brandon Hunt International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-06 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B212PNSTENC2 | K170672 | 000 |
| B212H938533101 | K170672 | 000 |
| B21257220R2 | K170672 | 000 |
| B212572201 | K170672 | 000 |
| B21257220100 | K170672 | 000 |
| B21257220100RFID0 | K170672 | 000 |