Nova Gauze(R) Disposable Nonwoven Sponges, Sterile
FDA 510(k) K915530 · American Threshold Industries, Inc.
510(k) numberK915530
Submission
- Device name
- Nova Gauze(R) Disposable Nonwoven Sponges, Sterile
- Applicant
- American Threshold Industries, Inc.
Enka, NC, US - Received
- December 10, 1991
- Decision date
- August 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K051918 | Resolve Open Back Halo RingsHAX · Special | Jerome Medical | 08/17/2005SE |
| K023959 | Jerome Glass RingHAX · Traditional | The Jerome Group, Inc. | 02/21/2003SE |
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| K980689 | Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional | Friddle'S Orthopedic Appliances, Inc. | 02/18/1999SE |
| K930021 | J TongsHAX · Traditional | Jerome Medical | 12/06/1995SE |
| K954069 | Ace Cervical Traction Halozs, Tongs & PinsHAX · Traditional | Ace Medical Co. | 10/12/1995SE |
| K924606 | Bremer Imaging Tongs-Mri ModelHAX · Traditional | Bremer Medical, Inc. | 09/09/1993SE |
| K873693 | Levtech Composite Traction TongsHAX · Traditional | Levtech, Inc. | 02/05/1988SE |
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| K953878 | Bouffant CapFYF · Traditional | 01/05/1996SE |
| K952115 | Barrier Gown, Kool-Gard Backless GownFYC · Traditional | 09/25/1995SE |
| K952114 | Kool Gard Singles GownFYC · Traditional | 09/25/1995SE |
| K952116 | Cover GownFYC · Traditional | 09/05/1995SE |
| K934085 | Modification of Surgical Eyeshield MaskHOY · Traditional | 11/12/1993SE |
| K915740 | Disposable O.R. Towel, SterileKKX · Traditional | 06/22/1992SE |
| K912110 | Disposable O.R. TowelKKX · Traditional | 07/25/1991SE |
| K894383 | Disposable Shoe CoverFXP · Traditional | 09/12/1989SE |
Questions and answers
When was Nova Gauze(R) Disposable Nonwoven Sponges, Sterile cleared by the FDA?
Nova Gauze(R) Disposable Nonwoven Sponges, Sterile (K915530) received a 510(k) decision of Substantially Equivalent on August 17, 1992, 251 days after the submission was received.
What is the product code of K915530?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.