Custom Pack Reliability
Medical device manufacturer in Orlando, FL.
21510(k) clearances
0PMA approvals
0recalls
Device types
- FRG Wrap, Sterilization 7
- FCM Tray, Catheterization, Sterile Urethral… 2
- KKX Drape, Surgical, Antimicrobial 1
- LWI Ultrasound, Sinus 1
- FAQ Bag, Urine Collection, Leg, For External… 1
- BYY Tube, Aspirating, Flexible, Connecting 1
- GCX Apparatus, Suction, Operating-Room, Wall… 1
- GDY Gauze/Sponge, Internal, X-Ray Detectable 1
- KYZ Syringe, Irrigating (Non Dental) 1
- GAW Suture, Nonabsorbable, Synthetic… 1
- JOL Catheter And Tip, Suction 1
- HHK Curette, Suction, Endometrial (And… 1
- MLS Labor And Delivery Kit 1
- BTO Tube, Tracheostomy (W/Wo Connector) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K960205 | CPR Tracheotomy Care TrayBTO · Traditional | 08/27/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | 05/23/1996SE |
| K960239 | CPR D & C TrayHHK · Traditional | 05/23/1996SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | 04/15/1996SE |
| K960213 | CPR Total Hip PackFRG · Traditional | 04/12/1996SE |
| K960211 | CPR Total Knee PackFRG · Traditional | 04/12/1996SE |
| K960210 | CPR Ortho Hand PackFRG · Traditional | 04/12/1996SE |
| K960206 | CPR Dressing Change TrayFRG · Traditional | 04/12/1996SE |
| K960209 | CPR Heart PackGAW · Traditional | 04/04/1996SE |
| K960215 | CPR Urethral Catheter TrayFCM · Traditional | 04/01/1996SE |
| K960214 | CPR Foley Cahteter KitFCM · Traditional | 04/01/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | 04/01/1996SE |
| K960238 | CPR Suture Removal KitFRG · Traditional | 03/28/1996SE |
| K960236 | CPR Lap SpongesGDY · Traditional | 03/28/1996SE |
| K960223 | CPR YankauerGCX · Traditional | 03/28/1996SE |
| K960218 | Connecting TubingBYY · Traditional | 03/28/1996SE |
| K960217 | CPR Urine BagFAQ · Traditional | 03/28/1996SE |
| K960208 | CPR Basic Set-Up TrayFRG · Traditional | 03/28/1996SE |
| K960241 | CPR General Surgery TrayLWI · Traditional | 03/22/1996SE |
| K960242 | CPR Eye TrayKKX · Traditional | 03/12/1996SE |
| K960207 | CPR Laceration TrayFRG · Traditional | 02/27/1996SE |