510(k) K801608
K801608 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "MCCULLEY CONTINUOUS SUTURE TIGHTNER". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code HND (Spatula, Ophthalmic), 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
- August 12, 1980
- Date Received
- July 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spatula, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type