510(k) K811887
K811887 is an FDA 510(k) premarket notification submitted by Sierra Laboratories, Inc. for the device "SKIN STAPLE EXTRACTOR". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code KBC (Saw, Nasal), a Class I device regulated under 21 CFR 874.4420. Sierra Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1981
- Date Received
- July 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saw, Nasal
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type