510(k) K864003
K864003 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Allergan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1986
- Date Received
- October 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type