The following data is part of a premarket notification filed by Hospitech Respiration Ltd. with the FDA for Ag Guffill.
| Device ID | K122721 |
| 510k Number | K122721 |
| Device Name: | AG GUFFILL |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | HOSPITECH RESPIRATION LTD. 31 HAAVODA ST Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy HOSPITECH RESPIRATION LTD. 31 HAAVODA ST Binyamina, IL 30500 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-05 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290015409039 | K122721 | 000 |
| 27290015409012 | K122721 | 000 |
| 27290015409005 | K122721 | 000 |