Beta Glucan Gel (Macropro Gel)
FDA 510(k) K002078 · Brennen Medical, Inc.
510(k) numberK002078
Submission
- Device name
- Beta Glucan Gel (Macropro Gel)
- Applicant
- Brennen Medical, Inc.
St. Paul, MN, US - Received
- July 10, 2000
- Decision date
- October 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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| K002077 | Glucanpro CreamMGQ · Traditional | 10/02/2000SE |
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Questions and answers
When was Beta Glucan Gel (Macropro Gel) cleared by the FDA?
Beta Glucan Gel (Macropro Gel) (K002078) received a 510(k) decision of Substantially Equivalent on October 2, 2000, 84 days after the submission was received.
What is the product code of K002078?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.