510(k) K880274
K880274 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS". The FDA issued a decision of Substantially Equivalent on Feb 5, 1988. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Advanced Surgical Products, Inc. has 63 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 1988
- Date Received
- Jan 21, 1988
- 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
- 510(k) Exempt