Surgical Eye Pack
FDA 510(k) K851906 · Xanmed Corp.
510(k) numberK851906
Submission
- Device name
- Surgical Eye Pack
- Applicant
- Xanmed Corp.
Washington, DC, US - Received
- May 1, 1985
- Decision date
- May 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMP – Pad, Eye
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4440
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940333 | Eye PadHMP · Traditional | Certified Safety Mfg., Inc. | 03/07/1994SE |
| K921349 | Sterile,Disposable Eye DressingHMP · Traditional | Deroyal Industries, Inc. | 05/29/1992SE |
| K904896 | Eye PadHMP · Traditional | Ulti-Med Intl., Inc. | 12/05/1990SE |
| K883822 | First Aid Kit, Eye Dressing NSN6545-00-853-6309HMP · Traditional | Consolidated Industries of Greater Syracuse, Inc. | 11/22/1988SESD |
| K874411 | Donaldson Natural Eyepatch 'Patient Pak'HMP · Traditional | Keeler Instruments, Inc. | 01/27/1988SE |
| K864810 | LidsplintHMP · Traditional | Precision Therapeutics, Inc. | 01/20/1987SE |
| K861456 | Sheets Lyophilized Collagen HeyedratorHMP · Traditional | Pantheon Products, Inc. | 07/25/1986SN |
| K860979 | Donaldson Natural EyepatchHMP · Traditional | Keeler Instruments, Inc. | 04/04/1986SE |
| K850099 | Visoprotect: Occular ShieldHMP · Traditional | Rockway Enterprises, Inc. | 03/20/1985SE |
| K850005 | Visoprotect Occular ShieldHMP · Traditional | M.S.G. Health Systems, Inc. | 03/20/1985SE |
More from M.S.G. Health Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864623 | Obstetrical/Gynecological Custom Surgical KitKNA · Traditional | 01/14/1987SE |
| K844595 | Orthopedic Custom Surgical KitLXH · Traditional | 08/21/1985SE |
| K844596 | Emergency Room & Minor Office Procedure Custom Kit · Traditional | 08/01/1985SESD |
| K844593 | Cardiovascular Custom Surgical KitDYB · Traditional | 06/21/1985SE |
| K844594 | Neuro Custom Surgical KitHBA · Traditional | 06/13/1985SE |
| K844597 | Miscellaneous General Surgical Custom Kit · Traditional | 04/08/1985SE |
| K843642 | Subclavian Lead Introducer SysDYB · Traditional | 10/23/1984SE |
| K843641 | Catheter Introducer SystemDYB · Traditional | 10/23/1984SE |
Questions and answers
When was Surgical Eye Pack cleared by the FDA?
Surgical Eye Pack (K851906) received a 510(k) decision of Substantially Equivalent on May 21, 1985, 20 days after the submission was received.
What is the product code of K851906?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.