American Brain Retractor Cover
FDA 510(k) K872951 · American Silk Sutures, Inc.
510(k) numberK872951
Submission
- Device name
- American Brain Retractor Cover
- Applicant
- American Silk Sutures, Inc.
Lynn, MA, US - Received
- July 28, 1987
- Decision date
- September 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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Questions and answers
When was American Brain Retractor Cover cleared by the FDA?
American Brain Retractor Cover (K872951) received a 510(k) decision of Substantially Equivalent on September 16, 1987, 50 days after the submission was received.
What is the product code of K872951?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.