Acromed Washers
FDA 510(k) K881699 · Buckman Co., Inc.
510(k) numberK881699
Submission
- Device name
- Acromed Washers
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- April 19, 1988
- Decision date
- April 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Acromed Washers cleared by the FDA?
Acromed Washers (K881699) received a 510(k) decision of Substantially Equivalent on April 27, 1988, 8 days after the submission was received.
What is the product code of K881699?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.