510(k) K822109
K822109 is an FDA 510(k) premarket notification submitted by Bio-Blitz, Inc. for the device "SHOVEL RETRACTOR". The FDA issued a decision of Substantially Equivalent on July 30, 1982. The device falls under product code NBH (Accessories, Arthroscopic), a Class I device regulated under 21 CFR 888.1100. Bio-Blitz, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1982
- Date Received
- July 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Arthroscopic
- Device Class
- Class I
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type