510(k) K991592

KSEA DE LA PLAZA BLEPHAROPLASTY SET by KARL STORZ Endoscopy-America, Inc. — Product Code HNI

K991592 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA DE LA PLAZA BLEPHAROPLASTY SET". The FDA issued a decision of Substantially Equivalent on November 2, 1999. The device falls under product code HNI (Retractor, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.