The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Adapt(tm) Universal Balloon Open Access Port.
| Device ID | K112456 |
| 510k Number | K112456 |
| Device Name: | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Natalie Smith |
| Correspondent | Natalie Smith Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2011-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14026704505194 | K112456 | 000 |
| 24026704645217 | K112456 | 000 |
| 34026704645207 | K112456 | 000 |
| 44026704559785 | K112456 | 000 |
| 24026704559774 | K112456 | 000 |