510(k) K780154
K780154 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "NEEDLEHOLDER, MICROVASULAR 5 1/2". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code HNM (Needle, Ophthalmic Suturing), a Class I device regulated under 21 CFR 886.4350. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1978
- Date Received
- January 30, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Ophthalmic Suturing
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type