The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Expandacell Injecto-pak.
| Device ID | K962133 |
| 510k Number | K962133 |
| Device Name: | EXPANDACELL INJECTO-PAK |
| Classification | Balloon, Epistaxis |
| Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Contact | Sarah M Lake |
| Correspondent | Sarah M Lake SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1996-08-01 |
| Summary: | summary |