510(k) K974032
K974032 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR". The FDA issued a decision of Substantially Equivalent on December 22, 1997. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1997
- Date Received
- October 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspirator, Endocervical
- Device Class
- Class II
- Regulation Number
- 884.1050
- Review Panel
- OB
- Submission Type